Warning letter
Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc.: warning letter of Jun 28, 2024
FDA warning letter 676984 · Center for Biologics Evaluation and Research (CBER)
Key facts
| Reference number | 676984 |
|---|---|
| Company | Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Jun 28, 2024 |
| Posted date | Aug 27, 2024 |
| Issuing office | Center for Biologics Evaluation and Research (CBER) |
| Product type | Biologics |
| CFR sections cited | 312, 211.42(c)(10)(iv), 211.100(a), 211.160(b), 1271, 1271.15, 1271.3(f)(1), 1271.10(a), 1271.10(a)(1), 1271.10(a)(3), 1271.75(a)(1), 1271.3(d) and 1 more |
| Inspection city | Richmond |
| Inspection ZIP | 94804 |
| Inspection start date | Sep 5, 2023 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: