FDA WARNING_LETTER - Gramercy Fertility Services - March 22, 2012

The FDA conducted an inspection of Gramercy Fertility Services from March 14-22, 2012, 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 Screen for Communicable Diseases:** Anonymous oocyte donors were not screened for risk factors for human transmissible spongiform encephalopathy (e.g., Creutzfeldt-Jakob disease) and xenotransplantation-associated communicable disease risks. 2. **Inadequate Screening for Tattoo/Piercing History:** Donors reporting tattoos or piercings within 12 months were not questioned to determine if sterile procedures were used. 3. **Lack of Donor Eligibility Documentation:** Records for several anonymous oocyte donors lacked documentation of a responsible person determining eligibility prior to donation. 4. **Inaccurate Donor Eligibility Records:** Donor records were missing physical examination documentation/dates, and a medical director's review date for test results preceded the actual test report date. 5. **Failure to Establish and Maintain Procedures:** * SOPs did not include xenotransplantation as a communicable disease risk factor for donor rejection. * SOPs did not describe the process for accepting donors recruited through agencies, leading to some donors lacking required personal interviews/medical history elaborations.

The FDA requires a written