# FDA 483 - Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - September 19, 2023

Source: https://www.globalkeysolutions.net/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/7326d811-b200-4ac7-ae4e-783a9762d90c

> FDA 483 for Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC on September 19, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
- Inspection Date: 2023-09-19
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC in Andover, MA, a biological drug substance manufacturer, was cited with three observations during an FDA inspection. The observations highlight significant concerns regarding process control, including the exclusion of continuous process verification data, inadequate temperature control for drug substance shipping, and an unjustified "non-CQA" designation for a critical attribute, indicating potential risks to product safety and efficacy.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/brantley-s-collins/c806aac1-3d89-4427-8aeb-6d9db6dfc2f4)
- [Gene D. Arcy](https://www.globalkeysolutions.net/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)
- [investigator](https://www.globalkeysolutions.net/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)

Company: https://www.globalkeysolutions.net/companies/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/0de9118f-18ec-45b8-b757-44f97c13c29c

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7