FDA EIR - Pfizer Pharmaceuticals, LLC - February 17, 2022

A routine cGMP surveillance inspection of Pfizer Pharmaceuticals LLC's Vega Baja, Puerto Rico site (now operating as Viatris) was conducted by the FDA from February 7 to February 17, 2022. The inspection covered the manufacture and packaging of human drug oral solid dosages, assessing Quality, Laboratory, Production, and Facilities and Equipment Systems under the FD&C Act and 21 CFR. The current inspection resulted in one observation on FDA Form 483: "testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release." This indicates a critical lapse in quality control before product market release. During the inspection, additional concerns were raised and acknowledged by management, including deviations in laboratory instrument qualification (e.g., dissolution bath qualification frequency, linearity tests for UV-VIS and Gas Chromatography) and a deficiency in the retain sample program's visual inspection procedure. A previous 2018 inspection had cited a failure to thoroughly review unexplained discrepancies. Mr. Jose Campos, Site Leader, committed to providing a written response to the FDA 483 observation within 15 business days. The FDA also warned of potential legal sanctions if the observed conditions are confirmed as regulatory violations. The firm acknowledged the raised concerns and indicated corrective actions would be implemented to ensure compliance with quality standards.