FDA 483 - Virginia Center for Reproductive Medicine - September 20, 2023

The FDA conducted an inspection of the Virginia Center for Reproductive Medicine, a reproductive human tissue establishment located in Reston, VA, from September 13 to September 20, 2023. The inspection revealed several significant compliance issues under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, specifically Section 704(b).

Key violations identified include the failure to establish and maintain appropriate procedures for testing human cell, tissue, and cellular and tissue-based product (HCT/P) donors. The facility's procedure manual inadequately specifies the timing for testing anonymous and directed donors for relevant communicable disease agents and diseases (RCDADs). Notably, the manual lacks provisions for HIV-1 NAT, HCV NAT, and HBV NAT testing, and incorrectly labels HCV testing as anti-HVC by NAT. Additionally, the manual fails to specify West Nile Virus (WNV) NAT testing and does not include a combo test for anti-HIV-1 and anti-HIV-2.

Further discrepancies were noted in the donor medical history questionnaire, which was outdated, and in the procedures for Zika virus screening, which inaccurately defined risk areas. The donor testing form also omitted critical test specifications.

The FDA requires the Virginia Center for Reproductive Medicine to address these deficiencies by updating their procedures and documentation to ensure compliance with federal regulations. The facility is encouraged to discuss any objections or corrective actions with the FDA or submit them for review.