FDA EIR - Pfizer Pharmaceuticals, LLC. - December 20, 2019

An FDA inspection of Pfizer Pharmaceuticals LLC in Barceloneta, PR, was conducted from December 10-20, 2019, covering active pharmaceutical ingredient (API) and human oral solid dosage products under drug manufacturing regulations. The inspection identified three key deficiencies. First, the quality control unit's procedures were not fully followed, with laboratory investigations being inadequately documented, untimely, and failing to evaluate potential trends, such as recurring “data loss” events. Furthermore, method changes were implemented locally without proper validation or method transfer. Second, corrective and preventive actions for manufacturing deviations were not effectively implemented, exemplified by a product defect library with blurry images and cleaning documents containing poor-resolution photographs, which hindered proper defect identification and procedural adherence. Third, batch production and control records were found to be incomplete, lacking documentation for specific manufacturing instructions for Doxazosin Mesylate GITS 4mg Tablets. In response, Pfizer management stated they would submit a written reply with further information to the FDA's Office of Pharmaceutical Quality Operations (OPQO) via email within 15 days, with no immediate corrective actions initiated during the inspection.