FDA EIR - Gemini Pharmaceuticals, Inc. - March 23, 2010

An FDA inspection of Gemini Pharmaceuticals, Inc., located in Commack, NY, was conducted from March 19-23, 2010. The inspection, carried out under the regulatory guidelines for Drug Manufacturing Inspections (C.P.7356.002) and animal drug operations (C.P.7371.001), focused on the company's quality, equipment, facilities, and laboratory systems. The company manufactures both human and animal over-the-counter drugs.

The inspection revealed several issues. An FDA-483 form was issued for two main violations: a lack of appropriate controls over computer systems, specifically granting unauthorized personnel, such as chemists, administrator privileges in critical HPLC software, which could compromise production records; and a failure to maintain backup files for raw data generated from the HPLC system. A verbal observation also noted that the accuracy and reproducibility of the UPLC test method for folic acid were not properly established and documented before multiple product batches were released.

Management at Gemini Pharmaceuticals agreed to the observations. The company promptly corrected the computer access issue by restricting administrator privileges to the lab manager and revised standard operating procedures to ensure comprehensive data backup. For the folic acid testing, the firm committed to re-analyzing affected batches and comparing the results. A written response to the FDA-483 observations was promised to the district office within 30 days.