FDA 483 - Foulk & Whitten Nevada Center For Reproductive Medicine - March 28, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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
ID · e3a45cfa-43cc-4aed-9ccc-391c0ebc9a5b