FDA 483 - Gemini Pharmaceuticals, Inc. - February 16, 2018

Gemini Pharmaceuticals, Inc. in Commack, NY, was inspected and cited for significant deficiencies in facility maintenance and adherence to written procedures. Observations included poorly maintained blending and pharmacy rooms leading to potential contamination, and failures to follow SOPs for material sampling and reserve sample management. These issues indicate a lack of control over manufacturing environments and quality processes.