FDA 483 - Fareva Richmond, Inc. - September 18, 2023

An FDA inspection of Fareva Richmond, Inc. in Henrico, VA, revealed significant deficiencies across multiple areas of its drug manufacturing operations. The firm failed to thoroughly investigate product discrepancies and batch failures, maintain proper facility hygiene, and ensure timely quality unit reviews. Additionally, the inspection found non-compliance with stability testing programs, inadequate employee GMP training, and a failure to follow written procedures for equipment maintenance, indicating a systemic lack of control over critical processes.