FDA EIR - Pfizer Inc. - September 22, 2017

A Food and Drug Administration (FDA) inspection was conducted at Pfizer Inc. Groton Laboratories from September 11 to September 22, 2017. This surveillance inspection, performed under FDA BIMO Compliance Program 7348.808 for Good Laboratory Practice (GLP) and covering nonclinical studies for human drugs (relevant to 21 CFR Part 58), identified two key issues. The primary violations included the failure to retain all raw data generated from nonclinical laboratory studies and the lack of adequate written records for critical equipment operations, specifically for inspection, maintenance, testing, calibrating, and standardizing. These observations were documented on a Form FDA 483. In response, Testing Facility Management stated their intent to submit a written response to the FDA. The inspecting district office recommended a 'Voluntary Action Indicated' (VAI) classification, signifying that while objectionable conditions were found, immediate regulatory action is not anticipated, awaiting final review and classification by the Center for Drug Evaluation and Research (CDER). A previous GLP inspection in 2014 also resulted in a VAI for different protocol adherence issues, which were not re-observed in this review.