FDA EIR - Gemini Pharmaceuticals, Inc. - June 01, 2011

An FDA inspection of Gemini Pharmaceuticals, Inc., a manufacturer of OTC drugs and dietary supplements, was conducted from May 25 to June 1, 2011, focusing on Quality and Material systems. The inspection, carried out under current Good Manufacturing Practices (cGMP) and regulatory frameworks like 21 CFR 211.110(a) and 21 CFR 211.166(a)(2), identified significant deficiencies. The main violations, documented on an FDA-483 form, included a failure to establish adequate control procedures for validating manufacturing processes, specifically regarding process drift evaluation during acetaminophen tablet compression. Furthermore, the firm's written stability program for drug products was found to be inappropriate, lacking defined storage conditions, a temperature mapping study for the stability room, clear timelines for sample testing, and procedures for handling temperature excursions. Verbal observations highlighted continued minor deficiencies in data backup procedures and concerns with the ongoing temperature mapping study at the company's new warehouse. In response, Gemini Pharmaceuticals, Inc. committed to revising its process validation and stability programs, implementing stricter protocols, and introducing an environmental chamber. The company also pledged to update data backup standard operating procedures and address warehouse temperature mapping issues, with formal written responses to the FDA-483 observations due within 15 business days.