FDA EIR - Patheon Manufacturing Services LLC - August 14, 2020

An FDA pre-license inspection was conducted at Patheon Manufacturing Services, LLC. in Greenville, NC, from August 10-14, 2020. This systems-based inspection, performed under pre-approval guidelines, focused on the manufacture of a specific drug product to support its application approval. The inspection resulted in a two-item FDA 483, identifying significant deficiencies. The first observation noted a failure of the quality unit to consistently follow procedures. This included a lack of documented rationale for facility upgrades, inadequate investigations into deviations such as turbulent airflow and microbial excursions, and insufficient training for personnel performing visual inspection of drug substance containers. The second observation highlighted an inadequate system for maintaining aseptic conditions within the manufacturing environment. Issues cited included inconsistencies in HEPA filter air velocity measurements when compared to standard operating procedures, and decisions for filter repair based on patch size rather than air integrity test results. Additionally, documentation for stored drug substance samples was found to be inconsistent. Management acknowledged these observations and committed to providing a formal response within 15 business days.