FDA EIR - Patheon Pharmaceuticals Inc. - December 13, 2019

Patheon Pharmaceuticals Inc. in Cincinnati, OH, underwent an FDA pre-approval inspection from December 9-13, 2019, for its Selumetinib 10mg and 25mg Capsules (NDA 213756). This inspection, governed by FDA's Pre-Approval Inspections guidance, aimed to assess readiness for manufacturing, conformance to application, and data integrity. The inspection revealed several deficiencies related to Good Manufacturing Practices (21 CFR Part 211).

The inspection concluded with a 4-item FDA Form 483. Key issues included the company's failure to consistently identify and reject defective in-process and finished products during visual inspections, particularly misaligned capsule bands. The firm also lacked established quantitative limits for critical, major, and minor defects during these visual checks. Furthermore, there were no written procedures for a critical deaeration visual endpoint, and batch production records did not include actual yield statements after capsule filling and banding operations.

These deficiencies led to an FDA recommendation for a "withhold" classification, signifying that Patheon Pharmaceuticals did not meet the "Readiness for Manufacturing" objective. The company acknowledged the observations and committed to submitting a written response to the FDA within 15 business days, outlining corrective actions.