# FDA WARNING_LETTER - Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. - September 25, 2023

Source: https://www.globalkeysolutions.net/records/warning_letter/berkeley-biologics-llc-previously-operating-as-elutia-inc-orthobiologics-business-unit-formerly-aziyo-biologics-inc/cd8dbff9-220e-4329-aab6-3cbef98efa0b

> FDA WARNING_LETTER for Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. on September 25, 2023. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc.
- Inspection Date: 2023-09-25
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research

## Related Documents

- [EIR - 2018-08-28](https://www.globalkeysolutions.net/records/eir/berkeley-biologics-llc-previously-operating-as-elutia-inc-orthobiologics-business-unit-formerly-aziyo-biologics-inc/a04b6654-ed79-4b27-90f3-9cf4ac068a30)

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/karlton-t-watson/fdf2a30c-35e0-4c1b-a676-af1350f55733)

Company: https://www.globalkeysolutions.net/companies/berkeley-biologics-llc-previously-operating-as-elutia-inc-orthobiologics-business-unit-formerly-aziyo-biologics-inc/d25bb436-149b-482e-b2e6-494161c126a4

Office: https://www.globalkeysolutions.net/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d