Virginia Center for Reproductive Medicine – FDA 483, Feb 25, 2019
The FDA inspected Virginia Center for Reproductive Medicine in Reston, VA, and issued a Form 483 with seven observations, many of which were repeat deficiencies. The inspection revealed significant issues with donor screening for communicable diseases, improper donor eligibility determinations, and inadequate record-keeping for human cells, tissues, and cellular and tissue-based products (HCT/Ps). These findings highlight persistent non-compliance in critical areas related to donor safety and quality control.
- Inspection date
- February 25, 2019
- Product type
- biologics
ID · 898ae4c0-17b6-4281-abf2-be12db608470
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