FDA EIR - Patheon Pharmaceuticals Inc. - March 01, 2017

An FDA inspection of Patheon Pharmaceuticals Inc. in Cincinnati, OH, was conducted from February 24 to March 1, 2017. The primary purpose was to investigate a Field Alert Report concerning stability failures of Glipizide ER 2.5mg capsules. The issues originated from a packaging configuration change, where Glipizide ER was moved from 60cc bottles without desiccant to 100cc bottles with desiccant. This change resulted in accelerated stability testing failures, specifically dissolution issues, which were attributed to the desiccant causing surface cracks and increased acid absorption in the tablets. This led to multiple voluntary recalls of affected Glipizide ER lots. Upon completion of the inspection, operating under FDA regulatory framework, the FDA issued a Form 483, citing a significant violation: Patheon Pharmaceuticals Inc. failed to adhere to its own "GMP Services Investigations" Standard Operating Procedure (SOP T510, Revision 14). Specifically, their investigation into the Glipizide ER stability failures identified root causes but neglected to define and implement necessary corrective or preventative actions to avoid similar issues with future packaging or desiccant changes. Management was informed of the findings and committed to providing a written response to the Cincinnati District Office within 15 business days, outlining their plan to address the identified observation and implement appropriate preventative measures.