Wyeth Pharmaceutical Division of Wyeth Holdings LLC – FDA 483
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.
- Product type
- biologics
ID · 101b2bfd-2277-4fc2-9114-49c8354e84d4
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