FDA EIR - PFIZER LABS - January 23, 2015

An FDA inspection of Pfizer Laboratories Div. Pfizer Inc. in Groton, CT, was conducted from January 20-23, 2015. This high-priority inspection assessed the company's control testing laboratory, responsible for stability testing of human and animal drugs, as well as active pharmaceutical ingredients (APIs). The inspection followed specific regulatory guidelines for Drug Manufacturing Inspections and Animal Drug Manufacturing Inspections, focusing on the quality and laboratory systems.

The inspection identified two significant observations, which were documented on an FDA Form 483. These deficiencies included inadequate method validation and equipment qualification processes, and a failure to maintain complete laboratory data. In response, the firm committed to providing detailed corrections through a written submission. Notably, previous issues from a prior inspection concerning the qualification of stability chambers had been successfully addressed by decommissioning the chambers and relocating all stability samples offsite.

The overall conclusion of the inspection was classified as Voluntary Action Indicated (VAI), signaling that the company's planned corrective actions are expected to resolve the identified issues. The FDA will maintain routine surveillance to ensure ongoing compliance.