# FDA WARNING_LETTER - Cooper Institute for Advanced Reproductive Medicine - July 19, 2021

Source: https://www.keypedia.com/records/warning_letter/cooper-institute-for-advanced-reproductive-medicine/6702d3f1-1114-4c6b-bc27-29c11c219b41

> FDA WARNING_LETTER for Cooper Institute for Advanced Reproductive Medicine on July 19, 2021. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Cooper Institute for Advanced Reproductive Medicine
- Inspection Date: 2021-07-19
- Product Type: Biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA conducted an inspection of Cooper Institute for Advanced Reproductive Medicine from July 8-19, 2021, 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 for communicable disease agents (21 CFR 1271.85(a))**: Anonymous oocyte donors were not tested for West Nile Virus (WNV) during the specified period, and one donor was not tested for HIV-1/2, HBV, HCV, and Treponema pallidum at the time of recovery.
2.  **Failure to test for genitourinary tract agents (21 CFR 1271.85(c))**: No record of testing for Chlamydia trachomatis and Neisseria gonorrhea for an anonymous oocyte donor.
3.  **Failure to document donor eligibility (21 CFR 1271.50(a))**: Records for multiple anonymous oocyte donors lacked documentation of donor eligibility determination, including the responsible person's name, date, and "eligible" status.
4.  **Failure to screen donors (21 CFR 1271.75(a))**: The donor questionnaire was missing screening questions for Zika Virus (ZIKV) risk factors, Creutzfeldt-Jakob

## Related Documents

- [483 - 2021-07-19](https://www.keypedia.com/records/483/cooper-institute-for-advanced-reproductive-medicine/66dde249-8505-4a4d-9e04-e4d253f2f72c)
- [483 - 2022-12-09](https://www.keypedia.com/records/483/cooper-institute-for-advanced-reproductive-medicine/9593851c-8051-4c29-9f1b-122aa7ab233e)
- [483 - 2023-11-16](https://www.keypedia.com/records/483/cooper-institute-for-advanced-reproductive-medicine/7781667f-1adf-42ef-be5c-df90023c96f1)

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/karlton-t-watson/fdf2a30c-35e0-4c1b-a676-af1350f55733)

Company: https://www.keypedia.com/companies/cooper-institute-for-advanced-reproductive-medicine/cd9a1da8-2714-4af0-9d40-c7bdb827234c

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1