Warning letter
Pharmakon Pharmaceuticals: warning letter of May 21, 2015
FDA warning letter 450088 · Detroit District Office
Key facts
| Reference number | 450088 |
|---|---|
| Company | Pharmakon Pharmaceuticals |
| Subject | Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Issue date | May 21, 2015 |
| Posted date | Jun 2, 2015 |
| Issuing office | Detroit District Office |
| Product type | Drugs |
| CFR sections cited | 211.167(a), 201.115 |
| Inspection city | Noblesville |
| Inspection ZIP | 46060 |
| Inspection start date | Mar 5, 2014 |
| 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: