FDA EIR - Patheon Biologics LLC - August 02, 2019

An FDA inspection of Thermo Fisher Scientific dba Patheon Biologics LLC in St. Louis, MO, was conducted from July 16 to August 2, 2019. This cGMP inspection, guided by Compliance Program 7356.002M and ICH Q7, identified several significant issues. The company received a six-item FDA Form 483, detailing observations such as inadequate procedures to prevent microbiological contamination, stemming from deficiencies in their environmental monitoring program and cleaning practices. The facility and equipment were not maintained in a good state of repair, evidenced by chipped paint on critical surfaces and equipment, and unsealed warehouse doors. The company also failed to adequately validate component supplier reports, specifically omitting purity testing for a key ingredient without proper justification. Furthermore, their equipment calibration and maintenance program was found lacking, with critical equipment not included or having outdated calibrations. Lastly, use logs for major critical equipment, like Biosafety Cabinets and Laminar Flow Hoods, were not maintained. Inadequate written procedures and building maintenance were repeat observations from a prior 2018 inspection. At the close of the inspection, management received a warning and was reminded of their responsibilities to adhere to the Food, Drug, and Cosmetic Act, necessitating prompt corrective and preventive actions to achieve compliance.