FDA 483 - Pharmacia & Upjohn Company LLC - May 20, 2021

Pharmacia & Upjohn Company, LLC, a subsidiary of Pfizer, Inc., received an FDA Form 483 following an inspection of its Kalamazoo, Michigan facility, a licensed biological drug manufacturer, from May 11-20, 2021. The inspection identified several critical deficiencies in Good Manufacturing Practices (GMP).

Primary issues included a lack of operator awareness during COVID-19 vaccine labeling and packaging, leading to unlabeled vials remaining on the production line, attributed to inadequate standard operating procedures. The firm also failed to thoroughly investigate unexplained discrepancies, specifically instances of microbial contamination found on personnel during aseptic processing of COVID-19 vaccine. These investigations were found insufficient due to the omission of critical product release data, such as sterility testing.

Furthermore, the FDA observed that written investigation records were incomplete, often lacking conclusions and follow-up actions. The company frequently failed to initiate necessary Corrective and Preventive Actions (CAPAs) and their subsequent effectiveness checks for various deviations, including foreign material contamination, broken glass incidents, and incorrect product volumes. Lastly, changes to validated cleaning processes were implemented without appropriate review and approval from relevant units like Validation/Qualification, impacting multiple drug substance lots. The company's internal procedure for managing changes was also deemed inadequate for ensuring comprehensive expert review. Pharmacia & Upjohn Company, LLC is expected to address these observations to ensure full compliance with regulatory requirements for drug manufacturing.