Warning letter
Rocky Mountain Pharmacy Inc.: warning letter of May 9, 2019
FDA warning letter 574231 · Center for Drug Evaluation and Research
Key facts
| Reference number | 574231 |
|---|---|
| Company | Rocky Mountain Pharmacy Inc. |
| Subject | Compounding Pharmacy/Adulteration/Misbranding |
| Issue date | May 9, 2019 |
| Posted date | May 28, 2019 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.165(a), 210.1(b), 201.115, 200.10(b), 211.67(b), 211.84(d)(2), 211.84(d)(6), 211.165(b) |
| Inspection city | Bozeman |
| Inspection ZIP | 59715-3580 |
| Inspection start date | Mar 6, 2018 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: