STATE OF FLORIDA oii EP DEPARTMENT OF HEALTH inated 2008 JUN 1A Hp: 05 DEPARTMENT OF HEALTH, DIVISION o¢ ADMINISTRATIVE PETITIONER, ; HEARINGS v. CASE NO. 2006-42868 TROYCO LIQUID NITROGEN, INC., RESPONDENT. / eee ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through its. undersigned counsel, and files this Administrative. Complaint against Respondent, Troyco Liquid Nitrogen, Inc., and in support thereof alleges: 1. Petitioner is the state agency charged with regulating Drugs, Devices, and ‘Cosmetics pursuant to Section 20.43, Florida Statutes and Chapter 499, Florida Statutes, 2. At times material to this Complaint, Respondent was 'a_ permitted Compressed Medical Gas Wholesaler and/or a Compressed Medical Gas Manufacturer within the state of Florida, having been issued permit numbers 31:00849 and 30:00302. 3. Respondent's address of record is 38800 US Highway 19 North, Tarpon Springs, Florida 34689. 4. A Department of Health investigator attempted to conduct a routine compliance inspection at the permitted location on December 12, 2006. The -. investigator discovered the location to be a public storage business. oe 5. Upon speaking with an employee of the public storage. business, it was confirmed that neither the Respondent, nor anyone affiliated with the Respondent, rented space there. 6. The Department of Health investigator contacted the owner of the Respondent company, Mr. Troy Muszynski, and was advised that he no longer rents there and has not had a space at that location for at least, over a year. 7. Mr. Troy Muszynski indicated that he was currently operating out of his residence located at 409 Mississippi Avenue, Palm Harbor, Florida 34684. | 8. When the investigator requested to inspect the business, ‘Mr. Muszynski advised the investigator that she could not come and inspect the premises. 9. _ Mr. Muszynski met with the investigator at the Department of Health office on February 16, 2007. At that time, Mr. Muszynski stated in writing that the address of the business was his personal residence and that he had operated the business there for about three years. Mr. Muszynski signed and dated this statement as February 16, 2007. A copy of this statement is attached as Petitioner's Exhibit A. 10. Mr. Muszynski was unable to provide any documentation regarding required policies and Procedures, compliance with current \Good Manufacturing Practices, or invoices of all transactions occurring in the last year. Invoices that were provided did not list the correct address of the company or the company’s permit numbers. li. After this meeting, the Department allowed the Respondent to maintain a temporary business at the public storage unit until more appropriate facilities were tu obtained. The Respondent was advised that the public storage unit is not a permanent solution and does not fulfill the facility requirements of Chapter 499, 12. The Respondent stated that his hours of operation would be 3:00 PM to 5:00 PM. 13. On March 1, 2007 the investigator attempted to meet with the Respondent at the public storage unit rented by Respondent and used as his place of | business. The investigator arrived at the rented unit at 3:40 PM and remained until 4:30 PM. No one was available at the facility. The investigator was again unable to conduct the inspection. -14. A Notice of Violation was sent by the Department to the permitted address of 38800 US Highway 19 North, Tarpon Springs Florida, 34689 on May 25, 2007. It was returned and was marked as return to sender, not at this address. A copy of the envelope is attached as Petitioner's Exhibit B-1. 15. A Notice of Violation was sent by the Department to the residence at 409 Mississippi Avenue, Palm Harbor, Florida 34683 on May 15, 2007. This Notice was returned and marked as “no mail receptacle.” A copy of the envelope is attached as Petitioner's Exhibit B-2. 16. On February 18, 2007 the Respondent sent an application to the Department of Health for a Compressed Medical Gases Wholesaler permit. The address listed for the place of business on this permit is 38800 US Highway 19 North, Tarpon Springs, Florida 34689, the public storage unit. The listed business hours are 3:00 PM to 5:00 PM. A copy of the application is attached as Petitioner's Exhibit C-1 to C-6. 17. The Department granted the new permit once the application was deemed complete on March 29, 2007. A new inspection was not required under the law since the Respondent was already a permit holder. COUNT ONE 18. Petitioner _realleges and incorporates paragraphs one (1) through seventeen (17) as if fully set forth herein. 19. Section 499.01(2)(b), Florida Statutes, specifically states that a permitted establishment can not be a residence. 20. Section 499.0121(1) and 499.0121(3), Florida Statutes, requires all permit holders under Chapter 499 to have an adequate facility. 21. The Respondent signed a written statement advising that he is operating ~ the business out of a residence and has been for approximately three years. 22. Based on the foregoing, the Respondent has violated Section 499.01(2)(b), 499.0121(1) and 499.0121(3), Florida Statutes. COUNT TWO 23. Petitioner realleges and incorporates paragraphs one (1) through seventeen (17) as if fully set forth herein. 24. — Section 499.01(5)(c), Florida Statutes, advises that any change must be submitted to the Department before the change occurs’ and Section 499.01(7)(a), Florida Statutes, requires that changes in address must be submitted to the Department © prior to the change. 25, The Respondent's written statement advises that he ceased operating from the permitted location approximately three years prior to the inspection. 26. The Respondent failed to notify the Department at any time before the change of address occurred. 27, Based on the foregoing, the Respondent has violated Section 499.01(5)(c) and 499.01(7)(a), Florida Statutes, COUNT THREE 28. Petitioner realleges and incorporates paragraphs one (1) through seventeen (17) as if fully set forth herein, 29. A constructive or direct refusal of an inspection of either the premises or the records is prohibited by Section 499.005(6), Florida Statutes. 30. The Respondent constructively refused an inspection of the premises by not being present at the permitted location during business hours on December 12, 2006 and March 1, 2007. 31. The Respondent directly refused an inspection of the premises during a call with the investigator on December 12, 2006. 32. Based on the foregoing, the Respondent violated Section 499.005(6), Florida Statutes. COUNT FOUR 33. Petitioner realleges and incorporates paragraphs one (1) through seventeen (17) as if fully set forth herein. 34. Section 499.006(3), Florida Statutes, states that a drug is considered adulterated if the manufacturer does not follow current good manufacturing practices. Activity with adulterated drugs is prohibited by Section 499.005(1) and 499.005(2), Florida Statutes, 35. The inadequate records, inadequate facility, inadequate policies and procedures, and inadequate maintenance records are a failure to follow current good manufacturing practices. 36. Therefore, all drugs, i.e. Compressed Medical Gases, are adulterated. 37. Based on the foregoing, the Respondent has violated Section 499.005(1)} and 499.005(2), Florida Statutes. COUNT FIVE 38. Petitioner realleges and incorporates paragraphs one (1) through seventeen (17) as if fully set forth herein. 39. Compressed Medical Gases Manufacturers are specifically required to abide by current good manufacturing practices in Section 499.013(2)(c)(3), Florida Statutes. 40. The inadequate records, inadequate facility, inadequate policies and procedures, and inadequate maintenance records are a failure to follow current good manufacturing practices, 41. Based on the foregoing, the Respondent has violated Section 499.013(2)(c)(3), Florida Statutes, COUNT SIX 42. Petitioner realleges and incorporates paragraphs one (1) through seventeen (17) as if fully set forth herein. 43. Recordkeeping and audit trail requirements state that records must be complete and accurate and must show the trail of the drug from its purchase to its disposition. A failure to maintain these records is prohibited by Section 499.005(18) and 499.0121(6), Florida Statutes. . 44, Invoices of all purchases and sales made in the prior year were not maintained. 45. The few invoices that were provided to the investigator did not list the correct address of the company or the company’s permit number as required by Florida Statutes. 46. Based on the foregoing, the Respondent violated Section 499.005(18) and 499.0121(6), Florida Statutes, COUNT SEVEN 47. Petitioner realleges and incorporates paragraphs one (1) through . seventeen (17) as if fully set forth herein. . . 48. Written policies and procedures are required by Section 499,0121(7), Florida Statutes. 49, The Respondent did not provide any written policies and procedures at the request of the investigator. 50, Based on the foregoing, the Respondent violated Section 499.0121(7), Florida Statutes. REQUEST FOR RELIEF 51. The Department may impose an administrative fine under the authority of Section 499.066(3), Florida Statutes. Section 499.067(3)(c), Florida Statutes allows for the Department to revoke the permit if a permittee has violated any section. of 499.001 — 499.081, Florida Statutes, or any rule enacted from those sections. The penalties are further spelled out in Rule 64F-12.024(4), Florida Administrative Code. This rule states that for violations of a severity level of 1, a revocation of the permit plus an administrative fine may be assessed. 52. Pursuant to Rule 64F-12.024(4) and the facts alleged in this complaint, the following fines are requested: a. The rule authorizes a fine for the inadequate facility (violation of 499.0121(1) and 499.0121(3) FS.) ranging from $250.00 - $1,000.00 per violation per day. A fine is requested. b. The rule authorizes a fine for changing address without prior notification (violation of 499.005(22) and 499.01(7)(a) FS.) ranging from $250.00 - $5,000.00 per violation per day and also authorizes the suspension or revocation of a permit with a fine. A fine and a revocation of the Respondent's permit is requested. c. The rule authorizes a fine for refusal of inspection (violation of 499.005(6) FS.) ranging from $500.00 - $5,000.00 per violation per day and also authorizes the suspension or revocation of a permit with a fine. A fine and a revocation ’ of the Respondent's permit is requested. d. The rule authorizes a fine for adulteration of a drug (violation of 499.005(1) and 499.005(2) FS.) ranging from $250.00 - $5,000.00 per violation per day and also authorizes the suspension or revocation of a permit with a fine. A fine and a revocation of the Respondent's permit is requested, €, The rule authorizes a fine for a failure to follow current good manufacturing practices (violation of 499.013(2)(c) FS.) ranging from $250.00 - $5,000.00 per violation per day and also authorizes the suspension or revocation of a permit with a fine. A fine and a revocation of the Respondent's permit is requested. f. The rule authorizes a fine for failure to maintain records (violation of 499,005(18) and 499.0121(6) FS.) ranging from $250.00 - $5,000.00 per violation per day and also authorizes the suspension or revocation of a permit with a fine. A fine and a revocation of the Respondent's permit is requested. g. The rule authorizes a fine for inadequate policies and procedures — (violation of 499.0121(7) FS.) ranging from $250.00 - $5,000.00 per violation per day and also authorizes the suspension or revocation of a permit with a fine, ‘A fine and a revocation of the Respondent's permit is requested. 53. The Notice of Violation previously attempted to be sent to the Respondent listed Administrative fines of one hundred six thousands dollars ($106,000.00.) This amount is permitted under Florida Statutes Chapter 499 and the corresponding rules due to the severity and extent of the Respondent's violations. A copy of this Notice is attached as Petitioner's Exhibit D-1 to D-4, 54, Based on the foregoing, Respondent has violated Chapter 499, Florida Statutes (2006) by failing to maintain a proper facility, by failing to submit .a change of address to the Department prior to the change, by constructive and express refusal of inspection of the facility and records, by aduiterating a drug, by failing to comply with Current good manufacturing practices, by failing to maintain complete and accurate records, and by failing to maintain policies and procedures. WHEREFORE, the Petitioner respectfully requests an order imposing the following penalty: revocation of Respondent's permit, assessment of an administrative fine in the amount of $106,000.00, or any other relief deemed appropriate. SIGNED this LD day of 2007. Ana M. Viamonte Ros, M.D., M.P.H. State Surgeon General Sarah J. Rumph / Assistant General Counsel DOH Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265 Florida Bar # 0653616. (850) 245-4640 (850) 245-4682 FAX one E ae ( pare eo OL Troyco Liquid Nitrogen, Inc., DOH Case No, 2006-42868 | nay Lrauie My tegie dec. cube hsseal Nddvecs bostne Stes 15 Alig! Yo 4 Whee resi pp ave Bivision of __ ADIN RIVE, Palen, ow how eu igs ARINGS. ae 727 9 qe Eo. <—e nets ee ee aT Te aia Sag iJ 7 ~ ~ a ~ ; _ wn ne ee — ee ve avrene ppsed ting tas | s bores —_—_ 4p oy — bon 4 ania epee wa | 04 ty, ef thee 18S PEAT ate Tray ele Aus Covered! - am Month + peut ble cei 2 outh we VA bay a _ may _ Davee) —5 thet, oo zo hove) [UM iv oerrck | i Sew ot... as het. spurt OW wh eines =, —s Sup ben ANtagas [tare Ma | Ha prek-vp \- 2K rs Orn A Mires (Wuidiesl) pick-op cy lider dalle Toqgkh ¢ (20Gb IH Bury Ta4wles a ae ae Taventery 5 PO Bitwos ot ota en Ae? RAE a) bok) a0 Vv Hquyxg | 7) 6897E BDNOTY ‘sduradg uodie ( : : L ‘ 4) A - BheEE es2 TOOO gese sode iii pce RG By - YON 61 Semusty S/n ooggE “OU “uaSOqIN pmbry ookory, . rysudzsnyy Aory “yw EO GO-TISE+SSIbe Loeze 3a0o diz Wous CAVA £002 BZAW Sa8lSGEPOGO obe°S0 $ vt 20 samo aguna soe Ay, c SEEN? MESS te Zz LOH a Basa DF * ey, 2 7E-66EZE BPUO|4 sasseyeyey tug ‘Aen ssaidAg pied 2gor WUP) Sed|AJag UONNDesoi4 Exhibit B-1 EGULATION 12 —rT = Tod z a. So LL go 5 ER s = a Ss Hc ~ S9ZE-6EEZE EPO easseyeyeL S9O# Ulg ‘Aefy sseidAn pleg zgop WUN Sed|Aleg UOYNoesOlg LOEZE 3000 dIZ Wous GAVIA ie L00Z SLAW EGISE gD o8E°SO + vi 20 Exhibit B-2 APPLICATION FOR A P oly ASSET ERMIT UNDER CHAPTER Florida Department of Health - Board of Phafiz ff P.O, Box 6320 - Tallahassee, Florida 32314-8: ‘This appllestian form Provides Information ag required by the Flarida Drug snd Cosmetic Act, Chante application signed by the authorized representative of the applicart will be Processed. Additional information This appilestion must be filled out in its entirety, Failure to de so will result Ina. fase I Received Date : 3/2007 Deposit Date : 342007 fee om, Deposit #: 187464 fon f.@ Batch Number: 001047373 Validation #: 9n6120104 Gheck Amount ; $640.00 P§O_GDE : 2334 MANUFACTURERS __ Prescription Drug Manufacturer __ Over-the-Counter Drug Manufacturer ____ Compressed Medical Gases Manufacturer __ Preseription Drug Repackager __ Device Manufacturer FE “ . COBMetic Manufacturer WHOLESALERS _ Veterinary Prescription Orug Wholesaler x Compressed Medical Gases Wholesaler —_— Retall Pharmacy Wholesaler ____ Nan-Realdent Prescription Drug Manufacturer } The applicant can apply for multiple perm va ‘oker Only, or Out-of-State Prescription wep , RESTRICTED PERMITS : Op ——. Restricted Prescription Drug Distributor - Reverse Distributor My ? Pa 2 & ___Fleatticted Prescription Drug Distributor « Destruction re @ i“ _—— Restricted Prescription Drug Distributor - Goverment Programs SY ___ Restricted Prescription Drug Distributor - Institutions! Research OTHER CATEGORIES Complimentary Drug Distributor __.. Veterinary Legend Drug Retailer ___ Medical Oxygen Retailer __ Freight Forwarder Ht 3 ie _— Restricted Prescription Drug Distributor - Health Care Entity __ Restricted Prescription Drug Diatributar - Charitable Organization if each permit requested fiption Drug it; use form DH 2124 Limited Veterinary Prescription Drug Wholesaler SEE REVERSE SIDE FOR APPLICATION FEES Ey sama ee ee aa eee ee seca St Nd cE Ma Fie MASERATI NEA OER thet +, cs 4 NAME OF APPLICANT (name in which company Is doing business; thie la the fname In which the perm will be decauied; lent to 41 characters) “Trotco Liquip a WhReGEW Tye 2 ee 00. (physica! locatton of establishment - thin addres should be faflected on ai! nates Invoices and shipping documentation) 3 SUITE NUMBER 00 U.S. bw Nontth 4 city 5 STATE 6 ZIP Tar pow ey (as FL 31o2q___ - 7 COUNTY 8 AREA CODE & LEPHONE NUMBER Ping blas Te7_- Guy. suas ennenee 112.21 > 1-1 Suds MoD: go Mi § :o0 7 ™ TAMME \ Het TU}: ve Mw hf :taUM 10 *pRovipe AN EMAIL ADDRESS WHERE REGULATORY UPDATES CAN BE SENT Ww » : 00 M19 rw’ fu 4 * FACSIMILE NUMBER WHERE REGULATORY UPDATES CAN BE SENT TH__ 3S: od nro: wef 11 -_4uy_ -_syay “NOTIFY THE DEPARTMENT IN WRITING OF ANY UPDATES 12 MAILING ADDRESS (8 diforent from physica! locadion; thia le where the renevas! application sind other official infarmation wil be sent by the department) 13 SUITE NUMBER D Boy 174 ae 14 CITY Ti : 15 STATE 18 ZIP. 1 RESIDENCE PHONE (Area Code & Nuinber) ciTy 1271 - _4@d - Go * POSITION/TITLE Hoq wmissigsipp: Ave wife /Booleksseer STATE ZIP ul Sh ob3 APPLICATION REVIEW Approved by Dats, Receipt Code Deposit No. Dented by Lory 3149127 G33, July 06 PERMT IS8UED Permit No. Eiraton Dea 3 13 / of Exhibit C-1 Entity Numbar : CALCULATING YOUR APPLICATION FEE Below you will find the permit(s) for which you are applying along with the associated application fee(s). Fill in the appropriate box(es) under “Amount" then add the boxes to calculate your Total Due." Make checks payable to the Drugs, Devices & Cosmetics Trust Fund, PERMIT TYPE APPLICATION FEE Preseription Drug Manufacturer $1,300,00 * Prescription Drug Repackager $1,300.00 * Device Manufacturer $7,000.00 * Cosmetic Manufacturer $600.00 * Compressed Medical Gases Manufacturer $900.00 * Over-the-Counter Drug Manufacturer $600.00 * Product Registration ( Or ¢ Migros Qudc) $20.00 X_2 (number of products) = Non-Resident Prescription Drug Manufacturer (see belaw) AMOUNT | 4o. go "it applying for multipla MANUFACTURING permits, you are only requited to pay for the one with tha highest fee, | in addition, all manufacturers, except Davice Manufacturers and Non-Resident Prescription Drug: Manufacturers, are required to register thelr products with the department prior to sale, Limited Veterinary Prescription Drig Wholesaler (In Florida) $1,000,00 Veterinary Prescription Drug Wholesaler (In Florida) $41,000,00 «Campressed Medical Gaees Wholesaler $500.00 Restricted Drug Distributor - Health Care Entity $500.00 Restricted Drug Distributor - Reverse Dletributor $500,00 Restricted Drug Distributor - Destruction $600.00 Complimentary Drug Distributor {In Florida) $500.00 Veterinary Legend Drug Retailer $500.00 Medical Oxygen Retaller $500.00 Freight Forwarder $250.00 Intteh\ppleetiontinspectionrFee— ® Alasaly Have Comprisssd Msdieg| Gases mMawu, Paceys Toe APPLICATIONS NOT REQUIRING AN INITIAL APPLICATIONINSPECTION FEE . Limited Veterinary Prescription Drug Wholesaler (Out-of-State) $1,000.00 Veterinary Prescription Drug Wholesaler (Out-of-State) $71,000,00 Complimentary Drug Distributor (Out-of-State) 500.00 Non-Resident Prescription Drug Manufacturer $860.00 Retail Pharmacy Wholesaler , 100,00 Restricted Drug Distributor - Charitable Organization $400.00 Restricted Drug Distributor - Government Programs $400.00 Restricted Drug Distributor - institutional Research $400.00 DH 1023, July 06 Total Dua Total Due soo. tH $40.09 — ee HUE Exhibit C-2 18 19 CORPORATE NAME OR LEGAL NAME IF DIFFERENT FROM APPLICANT NAME: TROCO Liaviy NytRogen c. el {cal set LIST ALL PARTNERS (use additional sheet if necessary) % OF OWNERSHIP NAME (Last, Firat, M1) . DATE OF BIRTH (mmidd/yy) TITLE (If applicable) (must total ta 100%) ! .€,, CEQ/COO, President, V.P., Sec., ‘Treas.); (use additional sheet if Necessary) NAME (Last, First, Ml) . DATE OF BIRTH (mmiddlyy) POSITIONTITLE % OF OWNERSHIP Ms 7X5 TROY 4 103 7 GS Pretiptd7 £02 % vappticadie Ul / % 1 applicoble ee —— § —. Tn eae FO 6H eppllcaba f / % i applicable nr ee ‘ / %6 ¥ appiicabla eee ee Hf yea, provide a listing of all parent companies with percentages of ownership. Ploase note that a peril issued purauart to this application is only valld'for the applicant's fame and address, THE NAME AND ADDRESS OF EACH MEN BER/MANAGER THE NAME AND ADDRESS OFTHE LLC,"THE RESIDENT AGE NT OF THE LLG, AND THE NAME OF THE STATE IN WHICH THE LLC WAS ORGANIZED a = is : ea 21 HAG THE APPLICANT, OWNER(S), MANAGER(S}IN-CHARGE, ANY OFFICER(S) AND/OR EMPLOYEES: YES NO ANY YES RESPONSE MUST BE DISCUSSED ON AN ATTACHED SHEET IN AS MUCH DETAIL AS POSSIBLE, . 1, BEEN FOUND GUILTY (REGARDLESS OF ADJUDICATION) OR PLED NOLO GONTENDERE IN ACOURT IN FLORIDA OR ANY OTHER JURISDICTION OF A VIOLATION OF LAW THAT DIRECTLY RELATES TO A DRUG, DEVICE, OR COSMETIC? 2. BEEN FINED OR DISCIPLINED BY A REGULATORY AGENCY IN ANY STATE (INCLUDING FLORIDA) FOR ANY OFFENSE THAT WOULD CONSTITUTE A VIOLATION OF CHAPTER 499, F.8.? 3. BEEN CONVICTED OF ANY FELONY UNDER A FEDERAL, STATE (INCLUDING FLORIDA), OR LOCAL LAW? 4. HAD ANY CURRENT OR PREVIOUS PERMIT OR LICENSE SUSPENDED OR REVOKED WHICH WAS ISSUED BY A FEDERAL, STATE OR LOCAL GOVERNMENTAL AGENCY RELATING TO THE MANUFACTURE OR DISTRIBUTION OF DRUGS, DEVICES, OR COSMETICS? Xx x 5. BEEN DENIED A PERMIT OR LICENSE RELATED TO AN ACTIVITY REGULATED UNDER CHAFTER 499, F.S,, INANY STATE? §. EVER HELD A PERMIT ISSUED UNDER CHAPTER 489, F.S., IN A DIFFERENT NAME THAN THE APPLICANT'S NAME? IF YES, PROVIDE THE NAMES IN WHICH EACH PERMIT: WAS ISSUED AND AT WHAT ADDRESS. Exhibit C-3 DH 1033, July 08 Page 2 of 3 re 22, ARE THERE ANY OTHER PERMITS (OR LICENSES FOR PHARMACIES OR PRACTITIONERS) {SSUED BY ANY AGENCY Ngge STA OF FLORIDA THAT AUTHORIZE THE PURCHASE OR POSSESSION OF PRESCRIPTION DRUGS AT THE APPLICANT'S ADDRESS? c ompreised vAeDi cal OMS why, - ¥ YES § NO - [fyes, provide the name in which the permit ia iseved, the parmit type anc permit number. iPoyeo Ligwp # iTMR@e? pne, z 23 CHECK THE APPROPRIATE BOX{ES) FOR THE TYPE OF PRODUCTS YOU WILL HANDLE: ___ Human Rx Veterinary Rx _. OTC Drugs 4 Oxygen Other Gases Cosmatics —_— Medical Devices ___Gontsoiled Substances (mark allthatappy) © _—SCHil SCH _—SSCHIV __ECHV _pravkiayour DEAS 24 TO WHOM DO YOU INTEND TO DISTRIBUTE YOUR PRODUCT(a) UNDER THE PERMITS FOR WHICH YOU ARE APPLYING? ___ Manufacturers ___ Wholesalers _¥, Proctitoners ___ Pharmacies ___ Hospitals ___ Clinics _ Public __ Patients ‘With a Prescription oH Veterinarians __ Other . 25 TYPEOF SALES: _Y\ Domestic(USA) __ Export 26 WHERE WILL THE REQUIRED RECORDS BE STORED AND MAINTAINED? FZ Anaticant Addresa Other (Explain): 27 ARE YOUR RECORDS AUTOMATED? ves —__NO If yes, do you have a back-up procedure to be able to provide required recorda?, YES DO YOU UNDERSTAND ELECTRONICALLY MAINTAINED RECORDS MUST REFLECT THE EXACT TRANSACTION WITHOUT UPDATES? . Xyes 28 DO YOU AGREE TO GOMPLY WITH CHAPTER 499, FLORIDA STATUTES, AND RULE CHAPTER 64F-12, F.A.C.7 A YES NO . Pe 1 hiaameniel — — erste stata ieee 29 D0 YOU UNDEHSTAND THAT YOU CANNOT BEGIN OPERATIONS iN OR INTO FLORIDA UNTIL A PERMIT HAS BEEN ISSUED? KyYes : __.NO 30 PROVIDE A LIST OF ALL COMPANIES YOU CURRENTLY OR AT ANYTIME HAD OWNERSHIP INTEREST? lo OTHE [wieAsT - YES Ano 31 1S THIS NEW APPLICATION RELATED TO A CHANGE OF OWNERSHIP? If yes, please include the parmit number of the current holder. VO 32 WHO SHOULD THE DEPARTMENT CONTACT WITH QUESTIONS REGARDING THIS APPLICATION? NAME (Last, First, Mj) . AREACODE & TELEPHONE NUMBER POSITION/TITLE. PSK (0 27 - CEC - $ UGY PCOS OEOT ADDRESS . : 409 Mississippi Ave CITY STATE Z\P CODE Pst HeY Ber FL Fu. 24695 - EMAIL ADDRESS FACSIMILE NUMBER (fax) Tamme pvt : 327. Guy -_SUGS COMPLETE THE QUESTIONS ON THE ATTACHMENTS RELATED TO THE SPECIFIC PERMITS FOR WHICH YOU ARE APPLYING. ATTACHMENTS MANUFACTURER (Rx, OTC, Device, Coamatic, Presctiption Drug Rapackagar) RETAIL PHARMACY WHOLESALER NON-RESIDENT PRESCRIPTION DRUG MANUFACTURER VETERINARY PRESGRIPTION DRUG WHOLESALER MEDICAL GASES (Manufacturer, Wholesaler, Medical 02 Retalier) VETERINARY LEGEND DRUG RETAILER RESTRICTED - HCE / CHARITABLE ORG, f GOVT PGMS / INST. RESEARCH COMPLIMENTARY DRUG DISTRIBUTOR RESTRICTED - REVERSE DISTRIBUTOR / DESTRUCTION FREIGHT FORWARDER AFFIDAVIT: 1 DO SOLEMNLY SWEAR AND AFFIRM THAT THE INFORMATION SUBMITTED TO THE DEPARTMENT ON THIS APPLICATION (must bo oamplated AND ANY ATTACHMENTS THERETO ARE TRUE AND CORRECT. ‘and notartead) 7 Pres tolent 2/ 18/07 Tite Date it signed by ‘ot officer identified In question #18, you must submit a {ottot of defopation for the signer to bind tha appicant, NOTARY STAMP OR SEAL ‘The foregoing instrument was sworn to before me this | % day of_FeBPUARY, 207 Stateot fF/ORID A ry 7hoY MUSZYNSIE/ on behalf of the applicant business, He/She countyof P/V ELLA Is WH pemonslly known to ma or has produced se identification, Notary Public (Sign Name Here): , a : GC, — ; Cong btakor/ Hau BEH AGEN Notary Public (Print Nama Here): Luis DP Un geuagen MY COMMISSION # DDazke99 EXPIRES: June 30, D DH 1033, July 06 Page 3 of 3 Exhibit C-4 MEDICAL GASES IF THE APPLICANT 1S APPLYING FOR A: COMPRESSED MEDICAL GAS MANUFACTURER COMPRESSED MEDICAL GAS WHOLESALER: OR MEDICAL OXYGEN RETAILER PERMIT, YOU MUST COMPLETE ALL SECTIONS ON THIS PAGE THAT ARE APPLICABLE TO YOUR ACTIVITIES AND SUBMIT AS A PART OF THE APPLICATION FOR A PERMIT UNDER CHAPTER 409, F.s, GENERAL QUESTIONS A. WILL YOU POSSESS MEDICAL GASEG AT YOUR ESTABLISHMENT? @ IF YOU INTEND TO TAKE POSSESSION OF MEDICAL GASES AT YOUR ESTABLISHMENT, DID YOU PASS A FIRE MARSHAL INSPECTION OF YOUR PREMISES FOR THE PURPOSE OF STORING MEDICAL GASES? YES x NO Provide us with a p COMPRESSED MEDICAL GAS MANUFACTURERS ONLY A. DO YOU INTEND TO COMPLY WITH ALL FEDERAL AND STATE "CURRENT GOOD MANUFACTURING PRACTICES AND GUIDELINES?” [_]res [Jno B. DO YOU INTEND To HANDLE GASES NOT FILLED BY YOU? YES __No If yes, 2 Compressed Medical Gas Wholesaler Permit fs required, C, DO YOWINTEND TO SELL OXYGEN To PATIENTS? YES NO Wf yes, a Madical Oxygen Ri permit in raquiredt, Gst provide ther FEACestiBlishiinent number or a y of the application you suimitted to the FDA) E. DO YOU UNDERSTAND THE PRODUCTS You MANUFACTURE MUST BE REGISTERED WITH TH Ff, ARE YOU SUBMITTING A PRODLT “APPLICATION? YES NO {f not, please explain: ~~ — x 9 8g te} 666 ce 25 Cc 3 OR 48 mn ze z 8 36 mS zo is} es oU°c 35 5a > wv =z = § gy fa a = 3 a m z'. x] & G m wu & Bz Oo F z a z a g S a So = —... Security/Alarm Systam ~ ‘Type:, clos & Procedures Addrassing: _ Quarantine Area Record Maintonance/RatrievalRetention Recalls and Widrewals | Disnstera/Declared Emergencies Dietributior/Dlaposition BEGINNING ON WHAT DATE WILL YOUR FACILITY BE AVAILABLE FOR INSPECTION? — 1 —. / Someone must ba af the establishment, on or ater this date, who can answer questions and show the agent around. COMPRESSED MEDICAL GAS WHOLESALERS ONLY “A. BO YOU INTEND To FILL MEDICAL GAS CONTAINERS AND SELL THESE TO NON-PATIENTS? _ YES" x NO “If yes, you must also obtain o Compressed Medical Gas Manufacturer perm, B. DO YOU INTEND To SELL OXYGEN TO PANENTS? YES’ Mino “i yes, you must nlea obtain a Medical Oxygen Retailer permit, C. DO YOU CURRENTLY HAVE THE FOLLOWING IN PLAGE? IF NOT, THEY MUST BE IN PLACE PRIOR TO THE ON-SITE INSPECTION, For halp on writing Policies & Procedures, review the form entliled Guidance on Drafting Pollcles & Procedures, or 5. 499.0121(7), F.8. _X. Securityiatarm system - type__AVTO /Tave _Xwitten Policies & Procedures Addressing: X ausrantine Area The Recaipt of Rx Drugs Record Maintenance/Ratrieval/Retention Storage Recalls and Withdrawals toventory Netural Disastere/Declamd Emerpencies Distrbution/Disposition BEGINNING ON WHAT DATE WILL YOUR FACILITY BE AVAILABLE FOR INSPECTION? 4 3 +8. 1 O77 Someone must be at the establishment, on of afer this date, who can answar questions and show the agent around, CONTINUED ON BACK Exhibit C-5 DH 1033, July 06 Seer —_ MEDICAL OXYGEN RETAILERS ONLY A. IF YOU TAKE POSSESSION OF MEDICAL OXYGEN, INCLUDING MAKING DELIVERIES, ANSWER THE FOLLOWING QUESTIONS: (if not, skip to question 8) 1, DO YOU INTEND TO FILL MEDICAL OXYGEN CONTAINERS? YES =__NO (Answer NO if you intend to have anather permit holder fill the tanks.) Hf yee, what ia your FDA establichment number? (You muat provide the FDA establishment number ore copy of the application you submitted to the FDA.) If yes, do you have labels of your product ready for inapaction? Do you intend to gall oxygen “HM yes, you wil) be required to obtai Ve refilled to a perzon other than a patlant? Compressed Medical Gas Manufacturer permit. BE IN PLAGE PRIOR TO THE ON-SITE INSPECTION, on Drafting Policies & Procedures, of 8, 499.0121(7), F.8. For help on writing Pollctes & Procedures, review the fois _ Security to Prevent Unauthorized Access to the Madical __Quaraniine Area Record Maintanance/RetriavalRetention Recalls and Withdrawals, Natural Disastere/Deciared Emergencies Distribution/Dispositian SKIP TO QUESTION IF YOU DO NOT TAKE POSSESSION AND DO NOT MAKE DELIVERIES OF MEDICAL OXYGEN, ANSWER THE FOLLOWING QUESTIONS: _ 1, IDENTIFY, BY NAME & ADDRESS, WHO WILL BE SUPPLYING THE OXYGEN TO YOUR PATIENTS. Your supplier must hald either a Compressed Medical Gases Manufacturer permit or a Compressed Macical Gases Wholesaler permit to sell to you, and a Medical Oxygen Retailer permit to deliver to your patients, 2 DO YOU CURRENTLY HAVE POLICIES & PROCEDURES IN PLACE ADDRESSING THE SUBJECTS BELOW? they must be in place prior to the on-site inspactian. . . Record Maintenance/Retriaval/Retantion Recalls and Withdrawals Natural Oisartara/Declared Emergent » BEGINNING ON WHAT DATE WILL YOUR FACILITY WAILABLE FOR INSPECTIO! Someone must be at the establishment; , whe can answer questions and show the agent around. . DO YOU INTEND TO SELL OR PROVIDE OXYGEN CONTAINER BRANCH) OTHER THAN A PATIENT? ROM ANOTHER ESTABLISHMENT TO A PERSON (INCLUDING ANOTHER DO YOU UNDERSTAND YOU CANNOT OPE! FOR EACH PATIENT , DO YOU UNDERSTAND THAT THE PRESCRIPTION, OR ORDER, IS ONLY VALID FOR ONE YEAR FROM WHEN IT WAS ORIGINALLY FILLED? = _YES No Exhibit C-6 DH 1033, July 06 Charlie Crist Ana M. Vi ‘oS, »>H. Governor een ic ak i hs CERTIFIED MAIL/RETURN RECEI REQUESTED! JUN TT A Ih Ob DIVISION OF NOTICE OF VIOLATION ADI MISTRAL IVE Case No.: 2006-42868 HEARINGS = Permit No.: 30:00302, 08:01834, 31:00849 May 25, 2007 Mr. Troy Muszynski Troyco Liquid Nitrogen, Inc. 38800 US Highway" LoNGHE” Tarpon Springs, FL .34689 Dear Mr. Muszynéki: 7 . Agents of the Department. of: Health. detected the fol wing Violations of the Florida Drug and Cosmetic Act, Florida, i Hlorida’ Regulations for.Drugs, Devices, and “wThese vio tions ‘were detected during "5 ahi oF A. The fadiy’ an records we : - inspection on December i This is.a violation of'Fi Department of Health: 31, 000.00. B. Change of.address without first. aotying the Department of Health: This is a violation of Florida Statutes Section 499.01(5) - Fine Assessed by the Department of Health: $1,000.00. C. Operating without a permit from an unapproved location for over three years. This is a violation of Florida Statutes Section 499.005(22) - Fine Assessed by the Department of Health: $100,000.00. D. Your company was not operating at the minimal number of hours per week. This is a violation of Florida Statutes Section 499.01 - Fine Assessed by the Department of Health: $1,000.00. 4052 Bald Cypress Way, Bin C-65 « Tallahassee, FL 32399 Exhibit D-1 850-245-4640: fax: 850-245-4682 * Charlie Crist Ana M, Viamonte Ros, M.D., M.P.H. Governor | Secretary of Health E. The delivery vehicle was not alarmed. This is a violation of Florida Statutes Section 499.0121(2) - Fine Assessed by the Department of Health: $1,000.00. F. Policies and d procedures were inadequate. This is a violation of Florida Statutes Section 499.0121(6) - Fine Assessed by the Department of Health: $1,000.00. G. Your company was not following current Good’ ManufactwrinePiieesses. This is:a yidlation of Florida Statutes Section 499, 01320 - ‘Fine Assessed by the Department ‘of Health: $1,000, 00." H, Company has been operating as a wholesale without a permit to:do so. ‘orfne will be assessed wane tient list’ OF. ‘a sficic Jacies that iolations 1 may not be limited to those facility is in-;compliance with all osmeétic Act andthe ‘Florida Administrative Code Regulations cited above. It-is your responsibi requirements of the Florida Drug. aii for Drugs, Devices, and Cosmetics. In order, to resolve this ‘matter, the Depaitment proposes the following alternatives, either..of which must be accomplished by your company within thirty (30) days of receipt of this letter: 1. If your company does not contest the findings in this letter, and further agrees to waive its right to an administrative hearing pursuant to Florida, Statutes 120.569 and 120.57, the Department and Troyco Liquid Nitrogen, Inc. may resolve this matter. If you agree to a resolution, please sign and date the enclosed Agreement. Return to me at the address on this letterhead: (a) The original signed Agreement, (b) A cashier's check, certified check, or money order for one hundred six thousand dollars ($106,000.00) made payable to the Florida Drug, Device and Cosmetic Trust Fund. Once the above listed two items are received, your case will be closed. 4052 Bald Cypress Way, Bin C-65 © Tallahassee, FL 32399 oe 4 850-245-4640: fax: 850-245-4682 Exhibit D-2 Charlie Crist . Ana M, Viamonte Ras, M.D., M.P.H. Governor Secretary of Health See 2. However, if you believe circumstances exist that the Department should consider before concluding this investigation, you may providé the Department your rationale and evidence to support your position within fifteen (15) days of receipt of this letter. If the Department does not agree with you, or we can not reach a satisfactory resolution of this matter, the Department may initiate appropriate legal action after expiration of the above referenced thirty (30) day time period. Appropriate legal action may include: (a) Filing and serving an administrative complaint for a hearing pursuant to Florida Statutes Chapter 120. This may result in the imposition of an administrative fine up to five thousand dollars ($5000.00) per violation per day. Each day the violation continues constitutes a separate violation, and each such separate violation is subject to a separaté*fii Administrative Complaint also becomes a matter of public record and is published on'the’Depattment of Health website. (b) Revocation or suspension of the company permit.- (c) ‘Seizure for destruction of adulterated or misbranded: products, (a) Seeking an injunction in-Circuit.Court té obtain.compliance. (e) Initiating any other-remedy-authorized:by'law. If you have any questions fegardt contact me at the address: sq. Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 ©. Tallahassee, FL 32399 Exhibit D-3 850-245-4640; fax: 850-245-4682 tD-3 Charlie Crist Ana M, Viamonte Ros, M.D., M.P.H, Governor Secretary of Health eee AGREEMENT Case No: 2006-42868 -Troyco Liquid Nitrogen, Inc. by and through its authorized agent hereby agrees to pay a fine of One Hundred Six Thousand dollars ($1 06,000.00); and acknowledges that : payment is enclosed with this Agreement. By signing this Agreement, Troyco Liquid ' Nitrogen, inc. agrees to waive its right to a hearing or appeal under Chapter 120, Florida Statutes, and waives and releases any other claim or right related to the Department of Health’s inspection, investigation, or notice:of violation-that has resulted in this Agreement “ Further, Troyco Liquid'Nitrogen, Inc. consents to this Agreementibeing adopted into a Tiled final order :of.:the:Departmentiof Health, and enforced in any:manner authorized by flaw. ote “ : . Corporate Seal: By: President (or.authorized' agent):*....., . Date... Attesied by: Corporate Secretary Date [Note this line only applies if the respondent is a corporation.] - Exhibit D-4 4052 Bald Cypress Way. Bin C-65 « Tallahassee. FL 32399 §5U-245-4640; tax: 850-245-4682

Docket for Case No: 08-002879