# FDA 483 - Wyeth Pharmaceutical Division of Wyeth Holdings LLC - November 18, 2022

Source: https://www.globalkeysolutions.net/records/483/wyeth-pharmaceutical-division-of-wyeth-holdings-llc/b2f02d0f-7174-4554-bf3b-9d9454e9ebe6

> FDA 483 for Wyeth Pharmaceutical Division of Wyeth Holdings LLC on November 18, 2022. Product: biologics. 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: 2022-11-18
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Wyeth Pharmaceutical Division of Wyeth Holdings LLC in Sanford, NC, a bulk vaccine manufacturer, identified deficiencies in written calibration procedures for instruments and analytical methods. Specifically, the firm failed to include specific limits for accuracy and precision for critical test sampling and did not properly utilize reference standards or bracket samples in analytical sequences. These issues indicate a lack of adequate control over critical testing processes.

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## Related Officers

- [Lewis Autwi](https://www.globalkeysolutions.net/people/lewis-autwi/7c0a9d04-adfe-4c90-b29f-7bc8245c76cc)
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Company: https://www.globalkeysolutions.net/companies/wyeth-pharmaceutical-division-of-wyeth-holdings-llc/05d2049f-ed44-40ae-8643-f957dc3c15f9

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7