Bayer AG – FDA 483, Jan 20, 2017

An FDA inspection conducted from January 12-20, 2017, at Bayer Pharma AG in Leverkusen, Germany, revealed significant deviations from Good Manufacturing Practices across its parenteral, solid oral dosage, and API drug manufacturing operations. Key observations included critical failures in maintaining appropriate environmental conditions during parenteral product filling, with inadequate monitoring, manual handling disrupting laminar flow, and unrepresentative smoke studies that posed contamination risks. Procedures for detecting particulate matter in parenteral products were deemed unreliable due to issues like obscuring cloudiness and inconsistencies between routine and qualification processes.

The inspection also identified substantial deficiencies in cleaning procedures, evidenced by residues on 'clean' equipment, lack of validation for hard-to-clean areas, and observed mold. Furthermore, the company lacked a robust document control system, leading to the unauthorized discarding of original batch records, analytical data, and training records, severely compromising data integrity. Complaint investigations were found to be insufficient, failing to extend to related batches, evaluate retain samples, or conduct necessary analytical testing. Additional issues noted included inadequate cross-contamination prevention, incomplete discrepancy investigations, and unsuitable facility/equipment design. Bayer Pharma AG is required to address these observations to ensure compliance with regulatory standards for pharmaceutical manufacturing.