FDA 483 - Patheon Biologics B.V. - September 20, 2018

An FDA inspection of Patheon Biologics, B.V. in Groningen, Netherlands, a drug substance and drug product manufacturing facility, revealed numerous deficiencies. The findings indicate significant issues with the firm's quality systems, including inadequate deviation management, laboratory controls, written procedures, cleaning validation, and equipment/facility maintenance. These observations highlight a lack of control over critical manufacturing processes.