# FDA 483 - Wyeth Pharmaceutical Division of Wyeth Holdings LLC - March 17, 2017

Source: https://www.keypedia.com/records/483/wyeth-pharmaceutical-division-of-wyeth-holdings-llc/020b7641-509c-477d-be4c-e22858cbf6d9

> FDA 483 for Wyeth Pharmaceutical Division of Wyeth Holdings LLC on March 17, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wyeth Pharmaceutical Division of Wyeth Holdings LLC
- Inspection Date: 2017-03-17
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Wyeth Pharm. Div. of Wyeth Holdings LLC, Pfizer Inc. in Pearl River, NY, was inspected and cited for multiple deficiencies related to sterile drug product manufacturing. Observations included failures in microbiological contamination prevention, inadequate quality control unit oversight, poor equipment maintenance, and insufficient laboratory and utility controls. These issues indicate a lack of adherence to GMP standards, potentially impacting drug product safety and quality.

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## Related Officers

- [Mate Tolnay](https://www.keypedia.com/people/mate-tolnay/3ab22485-0220-4930-b324-0db6a32e9008)
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Company: https://www.keypedia.com/companies/wyeth-pharmaceutical-division-of-wyeth-holdings-llc/85fd73c7-1b97-4ac5-bc70-53dfb31c37e5

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321