# FDA 483 - Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Unknown Date

Source: https://www.keypedia.com/records/483/wyeth-pharmaceutical-division-of-wyeth-holdings-llc/101b2bfd-2277-4fc2-9114-49c8354e84d4

> FDA 483 for Wyeth Pharmaceutical Division of Wyeth Holdings LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wyeth Pharmaceutical Division of Wyeth Holdings LLC
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: 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.

## Related Documents

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- [483 - 2023-11-10](https://www.keypedia.com/records/483/wyeth-pharmaceutical-division-of-wyeth-holdings-llc/0ba1c74f-85e2-4a5f-b9df-a2f55c5a93ad)
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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/scott-e-norris/8093919d-6e81-4629-8715-5e78be5c953a)
- [investigator](https://www.keypedia.com/people/jacqueline-m-diaz-albertini/9ff937fe-4e9b-445a-80fa-e26800d923b8)
- [investigator](https://www.keypedia.com/people/brantley-s-collins/c806aac1-3d89-4427-8aeb-6d9db6dfc2f4)

Company: https://www.keypedia.com/companies/wyeth-pharmaceutical-division-of-wyeth-holdings-llc/05d2049f-ed44-40ae-8643-f957dc3c15f9

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7