483
Dallas-Fort Worth Fertility Associates, P.A.Dallas-Fort Worth Fertility Associates, P.A. – FDA 483, Dec 9, 2019
Record Details
Dallas-Fort Worth Fertility Associates, P.A. in Dallas was inspected by the FDA, revealing a critical issue in their donor eligibility process. The firm was cited for determining an HCT/P donor eligible before receiving all required relevant communicable disease agent testing results. This practice indicates a failure to ensure donor safety and compliance with regulatory standards.
- Inspection date
- December 9, 2019
- Product type
- biologics
- Office
- Dallas District Office
- Person
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ID · a068f88a-cd8f-4133-bfc0-d63b9c274a34
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