Warning letter
Zions Rx Formulations Services LLC dba Rx Formuations Serv.: warning letter of Aug 15, 2014
FDA warning letter 436867 · Los Angeles District Office
Key facts
| Reference number | 436867 |
|---|---|
| Company | Zions Rx Formulations Services LLC dba Rx Formuations Serv. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Aug 15, 2014 |
| Posted date | Aug 26, 2014 |
| Issuing office | Los Angeles District Office |
| Product type | Drugs |
| CFR sections cited | 201.115, 211, 211.28(a), 211.42(c)(10)(iv), 211.42(c)(10)(vi), 211.113(b), 211.166(a), 211.167(a) |
| Inspection city | Mesa |
| Inspection ZIP | 85205 |
| Inspection start date | Dec 3, 2013 |
| Letter on fda.gov | web.archive.org |
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: