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

An FDA inspection of Pharmacia & Upjohn Company, LLC in Kalamazoo, MI, revealed significant deficiencies in manufacturing practices. The firm failed to follow procedures designed to prevent microbiological contamination of sterile drug products, leading to the release of potentially compromised lots. Additionally, employees lacked adequate training for specific operations, and deviations from production and process control procedures were not properly recorded or approved by quality.