Warning letter
Signature Biologics, LLC: warning letter of Sep 18, 2023
FDA warning letter 631039 · Division of Biological Products Operations II
Key facts
| Reference number | 631039 |
|---|---|
| Company | Signature Biologics, LLC |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Sep 18, 2023 |
| Posted date | Sep 29, 2023 |
| Issuing office | Division of Biological Products Operations II |
| Product type | Biologics |
| CFR sections cited | 1271.15, 312, 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.100(a), 211.113(b), 211.160(b), 211.166(a), 211.167(a), 1271, 1271.3(f)(1), 1271.10(a) and 3 more |
| Inspection city | Irving |
| Inspection ZIP | 75063 |
| Inspection start date | Dec 1, 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: