# FDA 483 - Sperm Bank, Inc - June 12, 2024

Source: https://www.globalkeysolutions.net/records/483/sperm-bank-inc/e7cff2cc-9784-4f3e-8fbe-fccae6a890f1

> FDA 483 for Sperm Bank, Inc on June 12, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sperm Bank, Inc
- Inspection Date: 2024-06-12
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Sperm Bank, Inc. in San Diego, CA, revealed significant deficiencies in donor eligibility determination and communicable disease testing practices. The firm failed to collect donor specimens at appropriate times and did not adequately test repeat anonymous semen donors for West Nile Virus (WNV) during the required season. Additionally, the company's internal protocols and donor screening forms were found to be outdated and insufficient for ensuring compliance with WNV screening requirements.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/kellie-l-thommes/255a1b92-cd56-41f5-9622-82e8a629e153)

Company: https://www.globalkeysolutions.net/companies/sperm-bank-inc/c1078c0d-e7d2-4107-a710-06d0d24a7184

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6