# FDA 483 - Pacific Reproductive Center - January 13, 2025

Source: https://www.keypedia.com/records/483/pacific-reproductive-center/c1f0e876-4da0-4939-ae9d-93d6f8eec61e

> FDA 483 for Pacific Reproductive Center on January 13, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pacific Reproductive Center
- Inspection Date: 2025-01-13
- Product Type: biologics
- Office Name: Los Angeles District Office
- Summary: Pacific Reproductive Center, Inc. in Torrance, CA, was inspected regarding its HCT/P reproductive establishment. The inspection revealed significant deficiencies in donor screening, eligibility determination, record-keeping, and labeling practices, particularly concerning communicable disease risks like West Nile Virus. These issues indicate a lack of adequate controls to ensure donor safety and product integrity.

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.keypedia.com/companies/pacific-reproductive-center/278b5bd8-d3e5-486a-bfad-4eeee6a416fd

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b