Warning letter
Nitrox, Inc. [ARCHIVED]: warning letter of Jul 26, 2010
FDA warning letter 109051 · Seattle District Office
Key facts
| Reference number | 109051 |
|---|---|
| Company | Nitrox, Inc. [ARCHIVED] |
| Subject | CGMP for Finished Pharmaceuticals/Adulterated/Misbranded |
| Issue date | Jul 26, 2010 |
| Posted date | Jul 26, 2010 |
| Issuing office | Seattle District Office |
| Product type | Drugs |
| CFR sections cited | 211.188(b), 211.192, 211.100(a), 211.100(b), 211.160(b), 211.165(a) |
| Inspection city | Lynnwood |
| Inspection ZIP | 98087 |
| Inspection start date | Mar 22, 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: