FDA WARNING_LETTER - Fertility and Reproductive Medicine Center for Women - November 12, 2009

The FDA inspected Fertility and Reproductive Medicine Center for Women, d/b/a: Viera Fertility Clinic, from November 4-12, 2009, and found significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Violations include: 1. **Failure to determine donor eligibility (21 CFR 1271.50(a))**: Prior to June 24, 2009, the firm failed to adequately test for Anti-hepatitis B core antigen, HIV-1, and HCV by NAT for several anonymous and one directed oocyte donor, leading to incomplete eligibility determinations. 2. **Failure to screen donors (21 CFR 1271.75(a)(1))**: Records for directed and anonymous donors lacked documentation of a donor medical history (social behavior) interview. 3. **Failure to ensure contractor compliance (21 CFR 1271.150(c)(1)(iii))**: The firm did not ensure that test kits used by its contractors for donor eligibility screening were FDA-licensed, approved, or cleared, or that it had knowledge of the kits used. 4. **Failure to establish and maintain procedures (21 CFR 1271.47(a))**: The "Egg Donor Eligibility Determination-