FDA 483 - Patheon Biologics LLC - July 30, 2019

Thermo Fisher Scientific dba Patheon Biologics LLC in St. Louis, MO, an API (Biotech) Manufacturer, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate procedures for preventing microbiological contamination in sterile processing, poor facility maintenance with chipped paint, and failures in validating supplier Certificates of Analysis. Additionally, the firm lacked proper equipment calibration and maintenance programs, failed to maintain equipment use logs, and did not consistently follow or contemporaneously document production and process control procedures.