Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc.
Warning letter issued June 28, 2024 · Richmond, California
- Inspection
- Sep 5 – Sep 25, 2023
- Pages
- 6
- FEI number
- 1000100754
In short: On June 28, 2024, FDA sent a warning letter to Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. in Richmond, California (FEI 1000100754).
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Questions about this warning letter
When was Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. inspected by FDA?
The inspection ran Sep 5 – Sep 25, 2023, and the Warning letter is dated June 28, 2024.
How do I get the full Warning letter for Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.