FDA 483 - Huntington Reproductive Center Medical Group - November 06, 2023
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An FDA inspection of Huntington Reproductive Center Medical Group in Pasadena, CA, a reproductive fertility center, revealed significant deficiencies in their handling of HCT/Ps. The firm failed to properly determine donor eligibility, quarantine HCT/Ps, and apply appropriate warning labels for products from donors who were not adequately screened or had reactive test results for infectious substances. These issues indicate a failure to ensure the safety and proper processing of human cells and tissues.
- Inspection Date
- November 6, 2023
- Product Type
- Biologics
ID · 7f9f8ce8-2d32-41d8-a9f5-78746144d351