# FDA 483 - Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - July 23, 2021

Source: https://www.keypedia.com/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/f26688a9-ebef-4b85-8e02-60e31c3b8b06

> FDA 483 for Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC on July 23, 2021. Product: drugs. 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: 2021-07-23
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC. in Andover, MA, a drug substance manufacturer, was cited for significant quality control and facility maintenance issues during an FDA inspection. Observations included insufficient data to support product quality, inadequate quality oversight, deficient deviation investigations, and widespread problems with cleaning validation and environmental monitoring. These issues indicate a lack of adherence to good manufacturing practices, potentially impacting the quality and safety of BNT162b2 drug substance and product.

## Related Documents

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- [483 - 2023-09-19](https://www.keypedia.com/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/7326d811-b200-4ac7-ae4e-783a9762d90c)

## Related Officers

- [investigator](https://www.keypedia.com/people/anissa-cheung/28959f30-f1e9-43a0-bec8-efd114e8cec2)
- [investigator](https://www.keypedia.com/people/kathleen-r-jones/3760ffcd-ce90-4b7c-b0a6-726edc8264d8)
- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.keypedia.com/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd