FDA EIR - Pfizer Inc. - July 18, 2018

A Pre-Approval Inspection (PAI) of Pfizer, Inc.'s Groton, CT facility was conducted by the FDA from July 9 to July 18, 2018. This inspection, carried out under Compliance Program 7346.832, aimed to assess the site's readiness for commercial manufacturing of Glasdegib tablet cores under New Drug Application (NDA) 210656. The evaluation focused on the firm's adherence to its application, the integrity of submitted information, and compliance with current Good Manufacturing Practices.

The inspection concluded with the issuance of a Form FDA 483, detailing three observations. Significant issues included an inadequate cleaning validation program for the tablet manufacturing system, which posed a risk of contamination from Celecoxib drug substance during Glasdegib production. Additionally, Pfizer did not follow its internal quality systems procedure for establishing Quality Acceptance Criteria for Glasdegib components. The firm also failed to comprehensively evaluate its manufacturing process and deviations before determining the disposition of Glasdegib tablet core batches.

Despite these findings, the inspection was classified as Voluntary Action Indicated (VAI). Based on Pfizer's written response to the observations, the FDA recommended approval of NDA 210656 for Glasdegib.