Warning letter
Pharmakon Compounding Pharmacy, Inc.: warning letter of Sep 7, 2017
FDA warning letter 523191 · Detroit District Office
Key facts
| Reference number | 523191 |
|---|---|
| Company | Pharmakon Compounding Pharmacy, Inc. |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Sep 7, 2017 |
| Posted date | Oct 10, 2017 |
| Issuing office | Detroit District Office |
| Product type | Drugs |
| CFR sections cited | 200.10(b), 211.42(c)(10)(iv), 211.42(c)(10)(vi), 211.113(b), 211.165(a), 211.167(a), 210.1(b) |
| Inspection city | Noblesville |
| Inspection ZIP | 46060 |
| Inspection start date | Apr 18, 2016 |
| Letter on fda.gov | fda.gov |
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: