# FDA 483 - Pur Biologics, LLC - December 04, 2025

Source: https://www.keypedia.com/records/483/pur-biologics-llc/7cf8ce41-eb69-4b23-b31d-9847f43971c1

> FDA 483 for Pur Biologics, LLC on December 04, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pur Biologics, LLC
- Inspection Date: 2025-12-04
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Pur Biologics, LLC, an HCT/P storage and distribution firm in Irvine, CA, was cited for significant deficiencies related to temperature monitoring and record-keeping during an FDA inspection. Observations included a failure to periodically review recorded storage temperatures and a lack of complete temperature records for human cell and tissue products. These issues indicate inadequate control over environmental conditions critical for HCT/P integrity.

## Related Officers

- [Eric Zhu](https://www.keypedia.com/people/eric-zhu/32919a8f-841a-441b-a489-8495f2e16993)

Company: https://www.keypedia.com/companies/pur-biologics-llc/449b851e-2680-4cb6-9319-5e9f5315e423

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