FDA WARNING_LETTER - Virginia Center for Reproductive Medicine - February 25, 2019

The FDA issued a Warning Letter to Virginia Center for Reproductive Medicine following an inspection from February 13-25, 2019, which revealed significant deviations from HCT/P regulations (21 CFR Part 1271). Key violations include: failure to test anonymous oocyte donors for relevant communicable diseases (HIV-1/2, hepatitis B/C, syphilis, gonorrhea, chlamydia) [21 CFR 1271.85(a)]; inadequate donor screening questionnaires missing critical risk factors [21 CFR 1271.75(a)(1)]; failure to deem ineligible donors with identified risk factors [21 CFR 1271.75(d)]; and failure of a responsible person to properly determine and document donor eligibility based on complete screening and testing [21 CFR 1271.50(a)]. Additionally, the firm failed to provide summaries of records accompanying HCT/Ps that list and interpret all communicable disease test results, specifically omitting West Nile Virus (WNV) testing [21 CFR 1271.55(b)(2)].

The FDA noted that a previous inspection in 2013 resulted in a Warning Letter for similar violations, indicating a failure to implement effective corrective actions. The firm's March 4, 2019, response to the current inspection was deemed inadequate, with revised forms still containing errors or omissions