FDA EIR - Pfizer Inc. - September 30, 2014

An FDA inspection of Pfizer Inc. Groton Laboratories in Groton, CT, occurred from September 16 to September 30, 2014. This surveillance inspection focused on Good Laboratory Practice (GLP) and Bioresearch Monitoring for Human Drugs, ensuring compliance with regulatory framework 21 CFR Part 58. The inspection was initiated at the request of the Center for Drug Evaluation and Research (CDER).

The facility's Drug Safety Research and Development (DSRD) unit, which conducts safety pharmacology and toxicology studies for human drugs and biologics, was a primary focus. Records reviewed included organizational charts, Master Schedules, Standard Operating Procedures (SOPs), study protocols, and raw data. Two studies were audited: "One Month Oral Toxicity Study of PF-06282999 In Dogs" and "46-Day Intravenous Toxicity Study of PF-06650808 in Monkeys with a 39-Day Recovery."

The main violation identified was documented on a one-item Form FDA 483 for study 13GR115. It stated that "The study director failed to assure that the protocol, including any change, was approved and was followed," indicating a procedural deviation. As a required action, Pfizer management committed to submitting a voluntary written response to the observation within 15 business days. The district office recommended a "Voluntary Action Indicated" (VAI) classification and referred the final classification to CDER, suggesting that corrective actions are necessary but do not require severe enforcement.