FDA 483 - Wyeth Pharmaceutical Division of Wyeth Holdings LLC

Wyeth Pharmaceutical Division of Wyeth Holdings LLC, a bulk vaccine manufacturer in Sanford, North Carolina, received a Form 483 with seven observations. The inspection revealed significant issues including incomplete deviation investigations, inadequate Quality Assurance oversight of off-site cell bank storage, and a failure to investigate initial out-of-specification results at the manufacturing level. Additionally, concerns were raised about cell bank storage locations, data integrity, and the completeness of responses to prior observations.