FDA EIR - Patheon Biologics LLC - November 10, 2023

An FDA inspection of Patheon Biologics LLC, Pharma Services-Thermo Fisher Scientific, located in St. Louis, MO, was conducted from November 3 to 10, 2023. This risk-based inspection, guided by CP 7356.002M and ICH Q7, focused on the manufacturing and testing of drug substance and covered Quality, Facilities & Equipment, Production, Material, and Laboratory Systems. The inspection identified six significant observations, documented on an FDA Form 483, indicating areas requiring improvement in adherence to good manufacturing practices. These violations included: inadequate standard operating procedures or failure to follow existing ones; insufficient Quality Assurance oversight of Corrective and Preventive Actions (CAPA) effectiveness; improper labeling of cGMP materials; substandard equipment maintenance; deficiencies in stability testing studies; and inadequate quality oversight of personnel training. Additionally, verbal observations noted issues with batch record documentation practices, laboratory procedure adherence, and cleaning protocols. Patheon Biologics LLC's management has committed to providing a written response addressing these inspectional observations within 15 business days.