483
Foulk & Whitten Nevada Center For Reproductive MedicineFoulk & Whitten Nevada Center For Reproductive Medicine – FDA 483, Mar 28, 2019
Record Details
An FDA inspection of Nevada Center For Reproductive Medicine, a human reproductive tissue establishment in Reno, NV, revealed significant deficiencies in donor screening practices. The firm failed to adequately screen donors for various communicable disease agents and lacked established procedures for determining donor eligibility and documenting ineligibility reasons for HCT/Ps. These findings indicate serious concerns regarding the safety and quality of donor tissues.
- Inspection date
- March 28, 2019
- Product type
- biologics
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ID · e3a45cfa-43cc-4aed-9ccc-391c0ebc9a5b
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