FDA 483 - Patheon Biologics LLC - January 24, 2023

The U.S. Food and Drug Administration conducted an inspection of Patheon Biologics LLC, Pharma Services-Thermo Fisher Scientific in Saint Louis, MO, from January 18 to January 24, 2023. This inspection resulted in an FDA Form 483, detailing multiple observations related to the firm's adherence to good manufacturing practices. Key issues included inadequate cleaning and preventative maintenance, evidenced by numerous mold recoveries exceeding action limits and multiple ceiling leaks in classified areas. The control of manufacturing processes was also found deficient, with a significant number of drug substance batches exceeding validated hold or processing times. Furthermore, the FDA noted incomplete risk assessments for specific unit operations, failing to adequately evaluate potential viral contamination risks from process splashing, solution use, and shared equipment. Other observations encompassed inadequate segregation of expired materials from materials for use in GMP manufacturing, deficiencies in the maintenance program for specific equipment, and poor raw material management, including the presence of long-rejected and expired materials in the GMP warehouse without defined disposal timelines. The inspection also highlighted inadequate internal specifications for treated water and insufficient labeling of GMP materials and equipment in manufacturing areas. Patheon Biologics LLC is required to provide a detailed response outlining comprehensive corrective and preventive actions to address these observations and ensure compliance with regulatory standards.