FDA 483 - Pharbest Pharmaceuticals, Inc. - September 15, 2025

An FDA inspection of Pharbest Pharmaceuticals, Inc. in Farmingdale, NY, revealed significant deficiencies across quality control, data integrity, equipment qualification, and stability programs. The firm failed to establish robust analytical data review, validate computer systems, maintain adequate data backups, and conduct proper stability and annual product reviews. These issues indicate a systemic lack of written procedures, validation, and oversight in critical manufacturing and quality assurance processes.