Warning letter
OsteoLife Biomedical I LLC: warning letter of Mar 31, 2022
FDA warning letter 626889 · Office of Biological Products Operations – Division I
Key facts
| Reference number | 626889 |
|---|---|
| Company | OsteoLife Biomedical I LLC |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Mar 31, 2022 |
| Posted date | May 31, 2022 |
| Issuing office | Office of Biological Products Operations – Division I |
| Product type | Biologics |
| CFR sections cited | 1271, 1271.195(c), 1271.220(a), 1271.160(b)(6), 1271.230(a) |
| Inspection city | Miami |
| Inspection ZIP | 33136 |
| Inspection start date | Dec 6, 2021 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 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: