Warning letter
Omega Tech Labs., LLC: warning letter of Oct 21, 2008
FDA warning letter 6586 · Seattle District Office
Key facts
| Reference number | 6586 |
|---|---|
| Company | Omega Tech Labs., LLC |
| Subject | CGMP for Finished Pharmaceuticals/Misbranded/Adulterated |
| Issue date | Oct 21, 2008 |
| Posted date | Oct 21, 2008 |
| Issuing office | Seattle District Office |
| Product type | Drugs |
| CFR sections cited | 310.544, 201.66, 211.22, 211.188, 211.192, 330.14, 201.66(b)(2), 347, 211.100(a), 211.165(a), 211.186(b)(9) |
| Inspection city | Boise |
| Inspection ZIP | 83709-1033 |
| Inspection start date | Jan 31, 2008 |
| Letter on fda.gov | web.archive.org |
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: