FDA EIR - Patheon Pharmaceuticals Inc. - January 14, 2020

Patheon Pharmaceuticals Inc. underwent an FDA post-approval and surveillance Good Manufacturing Practice (GMP) inspection at its Cincinnati, OH facility from January 7 to January 14, 2020. Conducted under relevant regulatory frameworks for post-approval and surveillance audits, the inspection covered general GMP compliance and specifically reviewed post-approval aspects for Sufentanil Sublingual Tablets 30mcg. Previous minor deficiencies from a 2018 inspection were confirmed as corrected during this visit. While no formal FDA Form 483 (Inspectional Observations) was issued, two significant concerns were verbally communicated to management. These included instances where Out-of-Specification (OOS) investigations were not initiated in a timely manner, with observed delays of up to 12 business days. Additionally, a specific laboratory OOS was found to have been invalidated without sufficient scientific justification, which does not align with regulatory expectations for robust investigation and resolution. Patheon's management acknowledged these findings and committed to reviewing and updating their internal procedures to ensure prompt initiation of all laboratory investigations and to establish scientifically sound criteria for OOS invalidation going forward.