Oct 16 2008 13:23 PAGE 83/87 DOH/GENERAL COUNSEL 16/16/2868 13:18 858-415-8743 STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, ¥ CASE NO. 2007-04043 = oe] SOUTH KENDALL MEDICAL o SERVICES, INC., & = RESPONDENT. a ADMINISTRATIVE COMPLAINT of Health, by and through its undersigned COMES NOW, Petitioner, Department counsel, and files this Administrative Complaint against Respondent, South Kendall Medical Services, 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 (2007) and Chapter 499, Florida Statutes (2007). At times material to this Complaint, Respondent was a permitted Medical Oxygen 2. Retailer within the state of Florida, having been issued permit number 32:3881. Respondent’s address of record is 10621 SW gg" Street, #122, Miami, Florida 3. 33176. 4, On or about January 11, 2007, Petitianer’s agent conducted a routine inspection at Respondent's premises pursuant to Section 499.051, Florida Statutes. 4. Upon request froma Petitioner's agent during the inspection referred to in sale records of purchase for medical Paragraph four (4), Respondent was unable to provide any oxygen tank refills, Oct 16 2008 13:23 la/le/2aee 13:18 858-413-8743 DOH/GENERAL COUNSEL PAGE @4/a7 6. On or about February 6, 2008, a second inspection was performed at Respondent's facility during which, upon request from Petitioner’s agent, Respondent was unable to provide any sale records of purchase for medical oxygen tank refills. 7 A medical oxygen retail establishment is defined in Section 499.0122(1)(a), Florida Statutes, as, “[a] person licensed to sell medical oxygen to patients only. 8. Section 499.01 22(2), Florida Statutes (2007), requires that a medical oxygen retail establishment must comply with all of the wholesale distribution requirements of Section 499.0121, Florida Statutes (2007). 9, Section 499,067(2), Florida Statutes (2007), provides that the Department may revoke the permit of any person who violates any provision of Section 499.001 -499.081, Florida Statutes (2007). 10. Recordkeeping and audit trail requirements state that records must be complete, accurate and must show the trail of the drug from its purchase to its disposition. A failure to maintain these records or failure to make the records readily available for inspection is prohibited by Section 499.005(18) and 499.0121(6), Florida Statutes (2007). lt. Rule 64F-12.012(1}(a), Florida Administrative Code, states “at a minimum, records shall consist of invoices of sale or other transfer by the person to the recipient”. 12. During the inspections referred to in Paragraphs four (4) and six (6), Respondent was unable to provide to Petitioner’s agent, invoices relating to the delivery and sale of oxygen tank refills. 13. Based on the foregoing, Respondent has violated Section 499.005(18) and 499.0121(6), Florida Statutes by failing to make records and/or audit trail documents available for inspection. Oct 16 2008 13:23 1 . = @/16/2888 13:18 858-413-8743 DOH/GENERAL COUNSEL PAGE 85/87 WHEREFORE, Petitioner respecitully requests an order imposing the following penalty: revocation of Respondent's permit, assessment of an administrative fine in the amount of $1,000.00, or any other relief deemed appropriate. - SIGNED this 77 day of Fe bew aed . 2008. Ana M. Viamonte Res, M.D., M.P.H. State Surgeon General oes Oheutl Diane Orcutt Deputy Division Director DOH Prosecution Services Unit 4052 Bald Cypress Way, Bin C-63 Talishassee, FL 32399-3265 Florida Bar # 0394572 (850) 245-4640 ip (850) 245-4682 FAX. by] i Depagrgenies dao Perry eHEALTH } one A Ra South Kendall Medical Services, Inc., DOH Case No, 2007-04043

Docket for Case No: 08-005171