483
Huntington Reproductive Center Medical GroupHuntington Reproductive Center Medical Group – FDA 483, Mar 28, 2023
Record Details
An FDA inspection of Huntington Reproductive Center Medical Group in Newport Beach, CA, identified two significant issues regarding Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to maintain donor anonymity by including identifying personal information on records for 31 anonymous oocyte donors. Additionally, donor eligibility was determined prematurely, prior to the completion of required screening and testing procedures.
- Inspection date
- March 28, 2023
- Product type
- biologics
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ID · 17add128-df50-4b8d-b3e9-532fc71c91dc
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