FDA 483 - Felix Generics Private Limited - August 27, 2024

Felix Generics Private Limited, a veterinary drug manufacturer in Dhar Madhya, India, was cited for significant deficiencies across its quality system during an FDA inspection. Observations included inadequate laboratory controls for HPLC warning messages, insufficient production and process control procedures, and deficient equipment cleaning validation. Furthermore, the firm failed to conduct thorough investigations into discrepancies and adverse events, and exhibited severe lapses in data integrity and document control.