Warning letter
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy: warning letter of Sep 8, 2020
FDA warning letter 610384 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 610384 |
|---|---|
| Company | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Sep 8, 2020 |
| Posted date | Sep 22, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 211.167(a), 201.115, 211.192, 200.10(b), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.94(d), 211.113(b), 211.165(a), 211.165(b), 210.1(b), 211.166(a) |
| Inspection city | Mesa |
| Inspection ZIP | 85207 |
| Inspection start date | Jun 5, 2019 |
| Letter on fda.gov | fda.gov |
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: