FDA 483 - Gemini Pharmaceuticals, Inc. - June 30, 2015

An FDA inspection of Gemini Pharmaceuticals, Inc. in Commack, NY, revealed significant deficiencies in their drug manufacturing operations. The firm was cited for issues including inadequate validation of packaging equipment, failure to annually inspect reserve drug product samples for deterioration, and incomplete batch production records lacking personnel identification. Additionally, the inspection found problems with laboratory controls, specifically the absence of written analytical procedures for OTC drug products and a lack of traceability for distilled water used in sample preparations.