Warning letter
Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts: warning letter of Oct 18, 2018
FDA warning letter 559540 · Detroit District Office
Key facts
| Reference number | 559540 |
|---|---|
| Company | Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Oct 18, 2018 |
| Posted date | Oct 18, 2018 |
| Issuing office | Detroit District Office |
| Product type | Drugs |
| CFR sections cited | 200.10(b), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.113(b), 210.1(b) |
| Inspection city | Wichita |
| Inspection ZIP | 67205 |
| Inspection start date | Jul 31, 2017 |
| Letter on fda.gov | fda.gov |
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: