# FDA 483 - Berkeley Biologics LLC - September 25, 2023

Source: https://www.keypedia.com/records/483/berkeley-biologics-llc/5de7399c-f0e6-415f-84ca-28214fcd8f6b

> FDA 483 for Berkeley Biologics LLC on September 25, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Berkeley Biologics LLC
- Inspection Date: 2023-09-25
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Elutia Inc. in Richmond, CA, was cited with five observations on a Form 483 inspection report. The inspection revealed significant issues with the validation of viable bone matrix manufacturing processes for several product lines, indicating a failure to prevent contamination. Additionally, the firm repeatedly determined donors with sepsis or septic shock eligible, lacked adequate procedures for donor eligibility, failed to provide complete medical records to the medical director, and used unqualified personnel for sepsis evaluations.

## Related Documents

- [EIR - 2021-09-07](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)

## Related Officers

- [Shelley R Beaureleit](https://www.keypedia.com/people/shelley-r-beaureleit/1126a5b2-6024-4e1c-9e30-4b64566b6ae8)
- [Richard L. Bartlett](https://www.keypedia.com/people/richard-l-bartlett/602337b9-ac77-41bb-a254-71a9d345335b)
- [Tonia T Hall](https://www.keypedia.com/people/tonia-t-hall/bd7e4ff0-ddde-44fb-bb4f-c6cf50b633fd)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b