FDA 483 - Patheon Softgels Inc. - July 17, 2025

An FDA inspection of ThermoFisher Scientific dba Patheon Softgels Inc in High Point, NC, from July 7-17, 2025, revealed significant deficiencies in quality control and manufacturing documentation. Observations included a failure to follow established cleaning and maintenance procedures for equipment, incomplete Quality Control Microbiology Laboratory notebooks lacking QA signatures and timely review, and deficient batch production records that did not accurately document manufacturing steps. These issues indicate a lack of adherence to established procedures and proper record-keeping practices.