Warning letter
TruVision Health LLC: warning letter of Nov 29, 2017
FDA warning letter 532286 · Denver District Office
Key facts
| Reference number | 532286 |
|---|---|
| Company | TruVision Health LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Issue date | Nov 29, 2017 |
| Posted date | Jan 2, 2018 |
| Issuing office | Denver District Office |
| Product type | Food/Cosmetics |
| CFR sections cited | 101, 101.2, 101.4, 101.5, 101.36, 111, 111.55, 111.105, 111.465, 101.3(g), 101.4(h)(1), 101.36(b)(1)(ii) and 20 more |
| Inspection city | Draper |
| Inspection ZIP | 84020 |
| Inspection start date | May 15, 2017 |
| 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: