# FDA WARNING_LETTER - Fertility and Reproductive Medicine Center for Women - November 12, 2009

Source: https://www.globalkeysolutions.net/records/warning_letter/fertility-and-reproductive-medicine-center-for-women/94e7c3bc-5e29-48c4-84df-d45b79c90fef

> FDA WARNING_LETTER for Fertility and Reproductive Medicine Center for Women on November 12, 2009. Product: Biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Fertility and Reproductive Medicine Center for Women
- Inspection Date: 2009-11-12
- Product Type: Biologics
- Office Name: Florida District Office
- Summary: The FDA inspected Fertility and Reproductive Medicine Center for Women, d/b/a: Viera Fertility Clinic, from November 4-12, 2009, and found significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Violations include:
1.  **Failure to determine donor eligibility (21 CFR 1271.50(a))**: Prior to June 24, 2009, the firm failed to adequately test for Anti-hepatitis B core antigen, HIV-1, and HCV by NAT for several anonymous and one directed oocyte donor, leading to incomplete eligibility determinations.
2.  **Failure to screen donors (21 CFR 1271.75(a)(1))**: Records for directed and anonymous donors lacked documentation of a donor medical history (social behavior) interview.
3.  **Failure to ensure contractor compliance (21 CFR 1271.150(c)(1)(iii))**: The firm did not ensure that test kits used by its contractors for donor eligibility screening were FDA-licensed, approved, or cleared, or that it had knowledge of the kits used.
4.  **Failure to establish and maintain procedures (21 CFR 1271.47(a))**: The "Egg Donor Eligibility Determination-

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)
- [Pamela W. Miles](https://www.globalkeysolutions.net/people/pamela-w-miles/08a3ccc2-1065-484b-9766-822dc01a2bc2)

Company: https://www.globalkeysolutions.net/companies/fertility-and-reproductive-medicine-center-for-women/53ae7f20-9726-4cbe-b8f6-b0e931d6f05f

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9