# FDA 483 - Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - January 17, 2019

Source: https://www.globalkeysolutions.net/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/a6583052-60a0-4c35-8b20-4c7cd6df9baf

> FDA 483 for Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC on January 17, 2019. 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: 2019-01-17
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC in Andover, MA, was inspected and cited for deficiencies in laboratory control mechanisms. Observations included a failure to properly establish and follow procedures for evaluating invalid GMP assays and investigating multiple assay failures, as well as inadequate documentation of instrument checks and maintenance for a spectrophotometer used in testing. These issues indicate a lack of robust quality control and data integrity practices.

## Related Documents

- [483 - 2017-04-28](https://www.globalkeysolutions.net/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/c8d75329-d72d-429e-9706-037dbe88a7d5)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/963fbbb7-ae34-41b3-b159-0019c8524637)
- [483 - 2019-05-03](https://www.globalkeysolutions.net/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/f5c92731-0fa2-4ec9-acaf-b10ee4f44051)
- [483 - 2021-07-23](https://www.globalkeysolutions.net/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/f26688a9-ebef-4b85-8e02-60e31c3b8b06)
- [483 - 2023-09-19](https://www.globalkeysolutions.net/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/7326d811-b200-4ac7-ae4e-783a9762d90c)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/jee-y-chung/0736677f-9719-44dc-9dab-60b610ac1a0a)
- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

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