FDA WARNING_LETTER - Manhattan Reproductive Medicine, PC - July 31, 2013

The FDA conducted an inspection of Manhattan Reproductive Medicine, PC, from July 26-31, 2013, identifying significant deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to determine donor ineligibility:** An anonymous oocyte donor tested positive for Chlamydia trachomatis twice but was deemed eligible, and oocytes were recovered. (21 CFR 1271.80(d)(1)) 2. **Failure to test for relevant communicable disease agents:** An anonymous oocyte donor was not tested for total antibody to Hepatitis B core antigen (anti-HBc) but was deemed eligible. (21 CFR 1271.85(a)) 3. **Failure to screen donors by reviewing medical records:** Donor medical history questions regarding communicable disease risk factors were not documented for multiple anonymous oocyte donors who were subsequently allowed to donate. (21 CFR 1271.75(a)(1)) 4. **Failure to use appropriate FDA-licensed tests:** The contract testing laboratory used tests not approved for HCT/P donor screening for Hepatitis C virus, HIV, and anti-HBc for several donors. (21 CFR 1271.80(c)) 5. **