Warning letter
Omega Laboratories Inc. [ARCHIVED]: warning letter of Feb 9, 2009
FDA warning letter 45738 · Cincinnati District Office
Key facts
| Reference number | 45738 |
|---|---|
| Company | Omega Laboratories Inc. [ARCHIVED] |
| Subject | Premarket Approval/Adulterated |
| Issue date | Feb 9, 2009 |
| Posted date | Feb 9, 2009 |
| Issuing office | Cincinnati District Office |
| Product type | Devices |
| CFR sections cited | 809.40, 807.81(b), 864.3260(a), 864.3260(b) |
| Inspection city | Mogadore |
| Inspection ZIP | 44260-1209 |
| Inspection start date | Feb 14, 2008 |
| Letter on fda.gov | web.archive.org |
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: