FDA 483 - Actavis Laboratories FL, Inc. - November 18, 2025

An FDA inspection conducted at Actavis Laboratories FL, Inc. dba Teva Pharmaceuticals from November 3 to November 18, 2025, identified significant deficiencies in compliance with current Good Manufacturing Practices (cGMP). The Form 483 document outlines four key observations indicating inadequate control over manufacturing processes and quality systems.A primary concern was the insufficient cleaning and maintenance of equipment, particularly non-dedicated machinery used for potent drug substances. The firm's reliance on visual cleaning verifications by production personnel proved unreliable, evidenced by numerous "visual failures" and the observation of visible drug residue in manufacturing areas days after production.Furthermore, the quality control unit demonstrated a lack of adequate authority and oversight, failing to properly review production records and identify non-contemporaneous data entries. The inspection also highlighted a systemic failure in thoroughly investigating unexplained discrepancies. Deviation investigations were deemed deficient, often lacking appropriate root cause identification, such as unsupported explanations for out-of-specification results and justifications inconsistent with validated clean hold times. Lastly, batch production and control records were found incomplete, specifically lacking documentation for critical steps like the collection of composite samples for product release.These observations, issued under the Federal Food, Drug and Cosmetic Act, require the company to implement comprehensive corrective actions to address these systemic issues and ensure product quality and patient safety.