FDA 483 - Pharmacia & Upjohn Company LLC - September 21, 2018

During an inspection from September 10-21, 2018, the FDA issued a Form 483 to Pharmacia & Upjohn Company, LLC, located in Kalamazoo, MI. The inspection revealed significant deviations from regulatory expectations for pharmaceutical manufacturing.The primary concerns included a failure to follow procedures designed to prevent microbiological contamination of sterile drug products. Specifically, the Quality Unit did not adequately investigate and address an environmental monitoring failure in an aseptic production suite, leading to the commercial release of potentially contaminated DEPO-MEDROL (Lot T09491) and putting other sterile products at risk.Additionally, the company was cited for insufficient employee training. Quality Assurance personnel tasked with validating critical laboratory spreadsheets, including those for drug product potency and microcount methods, lacked the necessary technical expertise.Finally, the FDA observed that deviations from established production and process control procedures were not properly documented or approved by the Quality Unit. Examples included undocumented quality approval for re-inspecting drug lots after a defect and exceeding validated manufacturing campaign lengths without appropriate cleaning and quality sign-off.These observations highlight concerns regarding the company's adherence to Good Manufacturing Practices, requiring Pharmacia & Upjohn Company to address these issues promptly with corrective actions to ensure product quality and patient safety.