# Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC – FDA 483, Jan 17, 2019

Source: https://www.keypedia.com/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: Division of Northeast Imports 
- 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 - 2023-09-19](https://www.keypedia.com/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/7326d811-b200-4ac7-ae4e-783a9762d90c) — date: September 19, 2023
- [483 - 2021-07-23](https://www.keypedia.com/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/f26688a9-ebef-4b85-8e02-60e31c3b8b06) — date: July 23, 2021
- [483 - 2019-05-03](https://www.keypedia.com/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/f5c92731-0fa2-4ec9-acaf-b10ee4f44051) — date: May 3, 2019
- [EIR - 2019-05-03](https://www.keypedia.com/records/eir/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/83e00d79-7a1e-4b09-9747-4ee3a4491903) — date: May 3, 2019
- [EIR - 2019-01-18](https://www.keypedia.com/records/eir/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/392f3626-23c7-42dd-a7fd-44bea43a306e) — date: January 18, 2019

## Related Officers

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

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-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94