Warning letter
ImprimisRx CA, Inc., dba ImprimisRx: warning letter of Mar 26, 2019
FDA warning letter 541375 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 541375 |
|---|---|
| Company | ImprimisRx CA, Inc., dba ImprimisRx |
| Subject | ImprimisRx CA, Inc., dba ImprimisRx, Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Mar 26, 2019 |
| Posted date | Apr 16, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 211.42(c)(10)(vi), 210.1(b), 211.113(b), 201.115, 211.42(c)(10)(iv) |
| Inspection city | Irvine |
| Inspection ZIP | 92618-4286 |
| Inspection start date | Mar 27, 2017 |
| 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: