# FDA 483 - Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - May 03, 2019

Source: https://www.keypedia.com/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/f5c92731-0fa2-4ec9-acaf-b10ee4f44051

> FDA 483 for Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC on May 03, 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: 2019-05-03
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Wyeth Biopharma Division of Wyeth Pharmaceuticals Inc. in Andover, MA, received a Form 483 for significant deficiencies in manufacturing controls, facility maintenance, and pest control. Observations included failures to follow written procedures, inadequate facility and equipment upkeep with multiple leaks and structural issues, and ineffective corrective actions for a persistent drain fly infestation. These issues indicate a lack of control over drug substance manufacturing and potential contamination risks.

## Related Documents

- [483 - 2017-04-28](https://www.keypedia.com/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/c8d75329-d72d-429e-9706-037dbe88a7d5)
- [483 - 2019-01-17](https://www.keypedia.com/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/a6583052-60a0-4c35-8b20-4c7cd6df9baf)
- [483 - Unknown Date](https://www.keypedia.com/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/963fbbb7-ae34-41b3-b159-0019c8524637)
- [483 - 2021-07-23](https://www.keypedia.com/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/f26688a9-ebef-4b85-8e02-60e31c3b8b06)
- [483 - 2023-09-19](https://www.keypedia.com/records/483/wyeth-biopharma-division-of-wyeth-pharmaceuticals-llc/7326d811-b200-4ac7-ae4e-783a9762d90c)

## Related Officers

- [Gunther H. Boekhoudt](https://www.keypedia.com/people/gunther-h-boekhoudt/b845bcf5-191b-4f26-bdd7-22b1b082cc1d)
- [Nailing Zhang](https://www.keypedia.com/people/nailing-zhang/d3814d08-b799-4de1-b901-1b90da0e0178)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)
- [issuing_officer](https://www.keypedia.com/people/amy-a-devlin/fed31d2d-96d0-4849-a167-92bec5d6d2be)

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