Wyeth Pharmaceutical Division of Wyeth Holdings LLC

FDA 483 - Wyeth Pharmaceutical Division of Wyeth Holdings LLC

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Record Details

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.

Company: Wyeth Pharmaceutical Division of Wyeth Holdings LLC
Product Type: Biologics
Office: Atlanta District Office
People: Scott E. Norris (issuing_officer)
Brantley S. Collins (investigator)
Jacqueline M. Diaz Albertini (investigator)

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ID · 101b2bfd-2277-4fc2-9114-49c8354e84d4