483
Huntington Reproductive Center Medical GroupHuntington Reproductive Center Medical Group – FDA 483, Oct 29, 2024
Record Details
An FDA inspection of Huntington Reproductive Center Medical Group in Newport Beach, CA, identified two significant observations concerning their HCT/P operations. The firm failed to properly determine donor eligibility based on screening questionnaires, specifically regarding a donor's travel history. Additionally, personal identifying information, such as dates of birth, was found on accompanying records for anonymous oocyte donors.
- Inspection date
- October 29, 2024
- Product type
- biologics
- Person
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ID · 12919cce-d37a-4a7e-a206-1ecca9544d86
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