Warning letter
Omega Tech Labs LLC: warning letter of Jul 23, 2024
FDA warning letter 679700 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 679700 |
|---|---|
| Company | Omega Tech Labs LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Issue date | Jul 23, 2024 |
| Posted date | Aug 6, 2024 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 211.166(a), 4, 211.22, 211.34, 211.84(d)(1), 211.113(a), 211.100(a) |
| Inspection city | Boise |
| Inspection ZIP | 83709 |
| Inspection start date | Jan 17, 2024 |
| 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: