Warning letter
Monarch Labs, LLC [ARCHIVED]: warning letter of Nov 9, 2010
FDA warning letter 120768 · Los Angeles District Office
Key facts
| Reference number | 120768 |
|---|---|
| Company | Monarch Labs, LLC [ARCHIVED] |
| Subject | CGMP for Medical Devices/QS/Adulterated |
| Issue date | Nov 9, 2010 |
| Posted date | Nov 9, 2010 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 820, 806.2(j), 806.10(a)(1), 806.10(b) |
| Inspection city | Irvine |
| Inspection ZIP | 92614 |
| Inspection start date | Jun 3, 2010 |
| 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: