FDA 483 - Wyeth Pharmaceutical Division of Wyeth Holdings LLC - December 17, 2025

Wyeth Pharmaceutical Division of Wyeth Holdings, Llc in Pearl River, NY, received a Form 483 for significant deficiencies in its manufacturing processes for sterile drug products. Observations included inadequate validation of aseptic processes, deficient sterilization testing methods, and insufficient sampling of incoming components. The findings indicate a lack of robust controls to prevent microbiological contamination and ensure product quality.