Warning letter
TG United, Inc.: warning letter of Aug 1, 2019
FDA warning letter 577583 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 577583 |
|---|---|
| Company | TG United, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Aug 1, 2019 |
| Posted date | Aug 20, 2019 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.63, 211.192, 341, 341.90, 211.67(a), 211.166(a), 341.72(d) |
| Inspection city | Brooksville |
| Inspection ZIP | 34604 |
| Inspection start date | Dec 17, 2018 |
| 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: