# FDA WARNING_LETTER - Gramercy Fertility Services - March 22, 2012

Source: https://www.keypedia.com/records/warning_letter/gramercy-fertility-services/3be8d527-399c-41aa-9278-31b484f64ae7

> FDA WARNING_LETTER for Gramercy Fertility Services on March 22, 2012. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Gramercy Fertility Services
- Inspection Date: 2012-03-22
- Product Type: Biologics
- Office Name: New York District Office
- Summary: 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

Company: https://www.keypedia.com/companies/gramercy-fertility-services/c15a33c3-5550-4c5c-837d-922febd8898a

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d