Warning letter
Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals [ARCHIVED]: warning letter of Feb 4, 2011
FDA warning letter 132110 · Florida District Office
Key facts
| Reference number | 132110 |
|---|---|
| Company | Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals [ARCHIVED] |
| Subject | CGMP for Finished Pharmaceuticals/Misbranded/Adulterated |
| Issue date | Feb 4, 2011 |
| Posted date | Feb 4, 2011 |
| Issuing office | Florida District Office |
| Product type | Drugs |
| CFR sections cited | 310.3(h), 101.3, 101.36, 101.5(a), 101.36(e)(1), 101.4(g), 101.36(b)(2), 101.36(e)(5), 101.54(b), 101.9(c), 201.66, 201.314 and 20 more |
| Inspection city | Miami Gardens |
| Inspection ZIP | 33014 |
| Inspection start date | May 24, 2010 |
| 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: