FDA 483 - Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - September 19, 2023

Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC in Andover, MA, a biological drug substance manufacturer, was cited with three observations during an FDA inspection. The observations highlight significant concerns regarding process control, including the exclusion of continuous process verification data, inadequate temperature control for drug substance shipping, and an unjustified "non-CQA" designation for a critical attribute, indicating potential risks to product safety and efficacy.