FDA 483 - Patheon Pharmaceuticals Inc. - September 26, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Patheon Pharmaceuticals Inc. in Cincinnati, OH, was cited for significant deficiencies in its quality control systems during an FDA inspection. The firm failed to thoroughly investigate out-of-specification results and implement corrective actions, and lacked written procedures for equipment cleaning and maintenance. Additionally, the quality control unit did not consistently follow its own procedures, leading to numerous overdue deviations and repeated issues, indicating a systemic breakdown in ensuring product quality.
ID · 46555dc2-dbe8-44e5-949c-8dcfdc5cf1f1