# FDA WARNING_LETTER - Sperm Bank, Inc. dba Fertility Center of California - June 12, 2024

Source: https://www.keypedia.com/records/warning_letter/sperm-bank-inc-dba-fertility-center-of-california/27a9e2f3-369c-46f8-bdac-f2fd9371476e

> FDA WARNING_LETTER for Sperm Bank, Inc. dba Fertility Center of California on June 12, 2024. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sperm Bank, Inc. dba Fertility Center of California
- Inspection Date: 2024-06-12
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: On February 14, 2025, the FDA issued a Warning Letter to Sperm Bank, Inc. dba Fertility Center of California following an inspection from June 7-12, 2024. The inspection revealed 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 relevant communicable disease agents:** Repeat anonymous semen donors were not tested for West Nile Virus (WNV) using an FDA-licensed NAT donor screening test at the time of the first donation within the June 1st to October 31st testing period.
2.  **Failure to perform complete donor screening:** Complete donor screening procedures, including review of relevant medical records (medical history interview and physical assessment), were not performed within the required six-month period for repeat donors before semen was released from quarantine.
3.  **Failure to collect donor specimens for testing within the required timeframe:** Specimens for communicable disease testing were not collected at the time of recovery or within seven days before or after recovery for multiple donors.
4.  **Failure to establish and maintain adequate procedures:** Procedures did not include WNV NAT as a required test for relevant communicable disease agents during the specified testing period.

The firm's June 25, 2024, response was deemed inadequate.

## Related Officers

- [Director](https://www.keypedia.com/people/melissa-j-mendoza/681d7777-4f19-4ecc-b31d-3272cb275c77)

Company: https://www.keypedia.com/companies/sperm-bank-inc-dba-fertility-center-of-california/9e54b18f-8132-48df-8ed8-81c2b98e1f7e

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d