# FDA 483 - Premier Sperm Donors - December 03, 2025

Source: https://www.keypedia.com/records/483/premier-sperm-donors/98bbdcf0-6698-4750-8d64-bfac4c7c4c91

> FDA 483 for Premier Sperm Donors on December 03, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Premier Sperm Donors
- Inspection Date: 2025-12-03
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Premier Sperm Donors, a sperm bank in Los Angeles, CA, was inspected by the FDA and cited for failing to adequately screen anonymous semen donors for communicable diseases. The firm's donor questionnaires were found to be insufficient in identifying risk factors for HIV, Hepatitis B, Hepatitis C, Smallpox, West Nile Virus, and Creutzfeldt-Jacob Disease. This indicates a significant lapse in donor eligibility determination practices.

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Company: https://www.keypedia.com/companies/premier-sperm-donors/3924f5fc-23d5-4f24-91db-c3090d5b3e89

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