FDA 483 - Gemini Pharmaceuticals, Inc. - June 01, 2011

An FDA inspection of Gemini Pharmaceuticals, Inc. in Commack, NY, a drug manufacturer, revealed two significant observations. The firm's compression process validation for Acetaminophen 500mg tablets was found deficient, failing to demonstrate consistent product specifications over time. Additionally, the written stability program for drug products lacked proper descriptions of storage conditions and failed to address temperature mapping and sample handling procedures.