# FDA 483 - Berkeley Biologics LLC - April 29, 2026

Source: https://www.keypedia.com/records/483/berkeley-biologics-llc/b334318a-9402-4bf2-aaa3-4459068b2461

> FDA 483 for Berkeley Biologics LLC on April 29, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Berkeley Biologics LLC
- Inspection Date: 2026-04-29
- Product Type: biologics
- Office Name: San Francisco District Office
- Summary: Berkeley Biologics LLC in Richmond, CA, a human tissue establishment, received a Form 483 with six observations, including repeat findings. The inspection revealed significant deficiencies in donor eligibility determinations for communicable diseases, inadequate oversight of contract manufacturing partners, and failures in deviation investigations and procedural controls. Additionally, the firm used unqualified reagents and had poor environmental controls in its tissue processing areas.

## Related Documents

- [EIR - 2011-09-07](https://www.keypedia.com/records/eir/berkeley-biologics-llc/0a475721-d76d-4337-a946-2cb52059506e)
- [EIR - 2016-03-25](https://www.keypedia.com/records/eir/berkeley-biologics-llc/f767d28d-239f-409e-9484-c74ecf77af8b)
- [EIR - 2021-06-25](https://www.keypedia.com/records/eir/berkeley-biologics-llc/6cac8334-1e00-423c-9754-6586db3609ff)
- [483 - 2023-09-25](https://www.keypedia.com/records/483/berkeley-biologics-llc/5de7399c-f0e6-415f-84ca-28214fcd8f6b)

## Related Officers

- [Shelley H. Beausoleil](https://www.keypedia.com/people/shelley-h-beausoleil/1212116b-e24d-4bbc-a27a-5c16334d573e)
- [Conor J. Mccarron](https://www.keypedia.com/people/conor-j-mccarron/280401e4-b080-4ba8-ab35-d3b16e91c2b1)

Company: https://www.keypedia.com/companies/berkeley-biologics-llc/a6e5270d-1ca1-40d3-830d-422cf9cb6f58

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df