FDA 483 - Wyeth Pharmaceutical Division of Wyeth Holdings LLC - March 17, 2017

Wyeth Pharm. Div. of Wyeth Holdings LLC, Pfizer Inc. in Pearl River, NY, was inspected and cited for multiple deficiencies related to sterile drug product manufacturing. Observations included failures in microbiological contamination prevention, inadequate quality control unit oversight, poor equipment maintenance, and insufficient laboratory and utility controls. These issues indicate a lack of adherence to GMP standards, potentially impacting drug product safety and quality.