# FDA EIR - Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. - August 28, 2018

Source: https://www.keypedia.com/records/eir/berkeley-biologics-llc-previously-operating-as-elutia-inc-orthobiologics-business-unit-formerly-aziyo-biologics-inc/a04b6654-ed79-4b27-90f3-9cf4ac068a30

> FDA EIR for Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. on August 28, 2018. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc.
- Inspection Date: 2018-08-28
- Product Type: Biologics
- Office Name: Office of Biological Product Operations
- Summary: A routine FDA inspection of Aziyo Biologics Inc. in Richmond, CA, was conducted from August 20-28, 2018. This inspection, part of the Office of Biological Product Operations' 2018 work plan, focused on human cells, tissues, and cellular and tissue-based products (HCT/Ps) in accordance with Compliance Program 7341.002. The inspection covered significant changes since the previous review, including the introduction of five new products like OsteGro, ViBone®, and the Altiply® amniotic membrane product lines. The scope also included a review of donor eligibility, manufacturing processes, labeling, and a new electronic system for managing tissue information. Notably, this electronic system was identified as not being Part 11 compliant, but the company clarified it was not used for official record-keeping, a statement verified during the inspection. Crucially, the inspection concluded without the issuance of an FDA Form 483 Inspectional Observations, indicating that no significant regulatory violations were found. Furthermore, a previously FDA-monitored recall was reviewed and found to have adequate corrective and preventative actions, leading to its official termination. Therefore, no specific regulatory actions were required from this inspection.

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## Related Officers

- [company_representative](https://www.keypedia.com/people/petar-georgiev/0a10fa0d-e670-4335-9e72-2527cd939689)
- [Shelley H. Beausoleil](https://www.keypedia.com/people/shelley-h-beausoleil/1212116b-e24d-4bbc-a27a-5c16334d573e)
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- [recipient](https://www.keypedia.com/people/peter-b-thompson/3f559269-262d-4c72-bb89-fca2b5710bb7)
- [company_representative](https://www.keypedia.com/people/mike-hennick/f0db48cb-e750-4c82-ac66-4bf6b76d08e4)

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

Office: https://www.keypedia.com/offices/office-of-biological-product-operations/7cd31f11-825c-4508-b091-d659fdc63ad9