Division of Administrative Hearings, Florida
Filed: Oct. 27, 1993
The issues in these consolidated cases are: (1) whether Petitioner, Department of Health, properly denied Respondent Discovery Experimental and Development, Inc.'s, application for a drug manufacturer's permit or, if the permit is deemed issued, whether the permit remains valid, and, if so, whether the Department may revoke such permit; (2) whether Respondents committed the offenses alleged in the Administrative Complaints and, if so, what administrative fine should be imposed; whether the Department of Health properly denied Respondent Discovery Experimental and Development, Inc.'s, application for an over-the-counter permit or any other approval; and whether the Department of Health properly denied Respondent Discovery Experimental and Development, Inc.'s, request to register its Silvicidal ES (extra strength) as a drug.Respondents manufactured for sale, sold, or otherwise distributed unapproved drug. Respondents also made false and misleading claims about its drug product. Recommend imposition of maximum administrative fine of $5000 per day during period of violations.
