# FDA 483 - Wyeth Pharmaceutical Division of Wyeth Holdings LLC - November 10, 2023

Source: https://www.keypedia.com/records/483/wyeth-pharmaceutical-division-of-wyeth-holdings-llc/0ba1c74f-85e2-4a5f-b9df-a2f55c5a93ad

> FDA 483 for Wyeth Pharmaceutical Division of Wyeth Holdings LLC on November 10, 2023. 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: 2023-11-10
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Wyeth Pharmaceutical Division of Wyeth Holdings LLC in Sanford, NC, from November 6 to November 10, 2023, identified a significant quality control issue. The firm failed to perform a required test on incoming starting material used in the manufacturing of Fidanacogene Elaparvovec. This indicates a potential lapse in ensuring the quality and safety of materials entering the production process.

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Company: https://www.keypedia.com/companies/wyeth-pharmaceutical-division-of-wyeth-holdings-llc/05d2049f-ed44-40ae-8643-f957dc3c15f9

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd