FDA 483 - Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - May 03, 2019

Wyeth Biopharma Division of Wyeth Pharmaceuticals Inc. in Andover, MA, received a Form 483 for significant deficiencies in manufacturing controls, facility maintenance, and pest control. Observations included failures to follow written procedures, inadequate facility and equipment upkeep with multiple leaks and structural issues, and ineffective corrective actions for a persistent drain fly infestation. These issues indicate a lack of control over drug substance manufacturing and potential contamination risks.