FDA EIR - Pfizer Inc. - February 24, 2012

An FDA inspection of Pfizer Laboratories, Div. Pfizer Inc. in Groton, CT, was conducted from February 21-24, 2012. This high-priority inspection focused on the control testing laboratory, which performs stability testing for both human and veterinary pharmaceutical products, including Tovias (fesoterodine fumarate) SR and tulathromycin active pharmaceutical ingredient. The inspection adhered to regulatory guidelines outlined in 7356.002 (Drug Manufacturing Inspections) and 7371.001 (Animal Drug Manufacturing Inspections), covering all applicable systems for a contract testing laboratory. The inspection identified a significant issue, resulting in a 1-item FDA Form 483 related to the qualification of a walk-in stability chamber. Specific violations included a lack of data demonstrating consistent temperature and humidity parameters when a subset of blowers were not functioning, the absence of an impact assessment for products stored during known blower malfunctions, and the failure to establish minimum and maximum load capacity ranges for the chamber. Pfizer management acknowledged the findings and committed to submitting a written response with proposed corrective actions within 15 business days. The FDA classified the inspection as "Voluntary Action Indicated (VAI)," requiring the company to implement these corrections, with subsequent routine surveillance planned. The company's initial response to the 483 was considered "Adequate, Requires Verification."