Warning letter
RTI Surgical, Inc.: warning letter of Nov 8, 2017
FDA warning letter 525318 · Florida District Office
Key facts
| Reference number | 525318 |
|---|---|
| Company | RTI Surgical, Inc. |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Nov 8, 2017 |
| Posted date | Nov 14, 2017 |
| Issuing office | Florida District Office |
| Product type | Biologics |
| CFR sections cited | 211.176, 211.188, 312, 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.80(a), 211.100(a), 211.113(b), 211.165(e), 610.12(d)(1), 1271, 1271.3(f)(2) and 4 more |
| Inspection city | Alachua |
| Inspection ZIP | 32615-6825 |
| Inspection start date | Apr 3, 2017 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- Yes Form FDA 483 issued
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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: