Pharbest Pharmaceuticals, Inc. – FDA 483, Nov 10, 2022

Pharbest Pharmaceuticals, Inc. in Farmingdale, NY, a human drug manufacturer, was inspected and received a Form 483 with seven observations. The inspection revealed significant deficiencies in data integrity, stability testing, investigation procedures, cleaning validation, equipment qualification, and routine equipment checks, indicating a broad lack of adherence to cGMP requirements.