Warning letter
Isomeric Pharmacy Solution, LLC: warning letter of Dec 12, 2016
FDA warning letter 511231 · Denver District Office
Key facts
| Reference number | 511231 |
|---|---|
| Company | Isomeric Pharmacy Solution, LLC |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Dec 12, 2016 |
| Posted date | Dec 27, 2016 |
| Issuing office | Denver District Office |
| Product type | Drugs |
| CFR sections cited | 201.115, 211.192, 200.10(b), 211.22(a), 211.42(b), 211.42(c)(10)(iv), 211.67(a), 211.100(a), 211.113(b), 211.166(a), 210.1(b) |
| Inspection city | Salt Lake City |
| Inspection ZIP | 84109 |
| Inspection start date | Jun 20, 2016 |
| 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: