FDA WARNING_LETTER - New Hope Fertility Center - September 15, 2014

The FDA issued a Warning Letter to New Hope Fertility Center following an inspection from August 26 to September 15, 2014, 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 test donor specimens for relevant communicable disease agents:** For example, an oocyte donor's specimen was not tested for Hepatitis B core antigen, HIV-1, and HCV by NAT, yet oocytes were recovered. 2. **Failure to determine ineligible donors with risk factors:** This includes a donor who tested positive for Chlamydia trachomatis (despite subsequent negative retest and antibiotic treatment) and a donor with a risk factor for vCJD due to European travel/residency. 3. **Failure to collect donor specimens within the specified timeframe:** Specimens were collected outside the 30 days prior to or 7 days after oocyte recovery for multiple donors. 4. **Failure to maintain complete documentation of donor screening:** Physical examination documentation for at least six donors was incomplete regarding communicable disease risk factors. 5. **Failure to maintain complete donor-eligibility determination documentation:** Records for multiple donors lacked documentation of "eligible" determination, the responsible person's name, or the date of determination. 6. **Failure to establish and maintain adequate procedures for