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

The U.S. Food and Drug Administration (FDA) conducted a pre-approval and surveillance Good Manufacturing Practices (cGMP) drug inspection of Pharmacia & Upjohn Company, LLC, a Pfizer company, located in Kalamazoo, MI. The inspection took place from September 10 to September 21, 2018, covering various systems including Quality, Facilities & Equipment, Materials, Production, and Laboratory. This assessment also supported the pre-approval of BLA 761099 for PF-06439535 (Bevacizumab) and post-approval for ANDA 062803 related to Clindamycin Phosphate Injection. The inspection resulted in a 3-item FDA Form 483, identifying significant deficiencies. These included a failure to adhere to procedures designed to prevent microbiological contamination of sterile drug products, insufficient employee training for specific operational tasks, and a lack of recorded deviations from established production and process control procedures. These findings echo a previous 2015 inspection which cited eight observations, highlighting recurring issues in quality control and manufacturing processes. As a required action, Pharmacia & Upjohn Company, LLC was instructed to submit a written response addressing these observations within 15 business days. The FDA classified the outcome as 'Voluntary Action Indicated,' indicating that the company is expected to implement corrective measures, with routine follow-up anticipated.