Warning letter
Smart Surgical, Inc dba Burst Biologics: warning letter of Feb 2, 2022
FDA warning letter 614361 · Office of Biological Products Operations – Division 2
Key facts
| Reference number | 614361 |
|---|---|
| Company | Smart Surgical, Inc dba Burst Biologics |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Feb 2, 2022 |
| Posted date | Feb 22, 2022 |
| Issuing office | Office of Biological Products Operations – Division 2 |
| Product type | Biologics |
| CFR sections cited | 211.42(c)(10)(iv), 211.192, 312, 211.84(a), 211.113(b), 211.165(e), 1271, 1271.15, 1271.3(c), 1271.10(a), 1271.10(a)(2), 1271.10(a)(4) and 4 more |
| Inspection city | Boise |
| Inspection ZIP | 83705 |
| Inspection start date | Feb 22, 2021 |
| 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: