FDA 483 - Pharmacia & Upjohn Company LLC - June 16, 2023

The FDA conducted an inspection of Pharmacia & Upjohn Company LLC's drug and biologic manufacturing facility in Kalamazoo, MI, from June 5 to June 16, 2023. The inspection revealed several significant observations indicating a lack of adherence to manufacturing quality standards.Key findings included the firm's failure to establish adequate written procedures for production and process controls. Specifically, practices for managing waste and cleaning manufacturing tanks created a risk of cross-contamination between potent and non-potent sterile products, including vaccine buffers. Facility design was also found to be unsuitable, with aseptic processing areas lacking physical barriers and proper monitoring of air pressure differentials, further compromising environmental control.Additionally, the Quality Control unit demonstrated insufficient oversight, failing to adequately review production operations for aseptic technique and intervention performance. Aseptic process validation was deficient, as media fills did not accurately represent routine interventions, and critical interventions were not always documented or included in airflow studies. Equipment design was suboptimal, with non-viable particle probes positioned too far from filling lines, impacting contamination monitoring. The inspection also noted inadequate aseptic cleaning procedures and a general lack of cleanliness and sanitation in manufacturing areas, including observed rouging and rust stains.These observations highlight significant deviations from Good Manufacturing Practices. Pharmacia & Upjohn Company LLC is required to promptly address these deficiencies by implementing comprehensive corrective and preventive actions to ensure the identity, strength, purity, and quality of its drug products, thereby protecting public health.