Warning letter
Empower Clinic Services, LLC: warning letter of May 25, 2017
FDA warning letter 516718 · Dallas District Office
Key facts
| Reference number | 516718 |
|---|---|
| Company | Empower Clinic Services, LLC |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | May 25, 2017 |
| Posted date | May 25, 2017 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 201.115, 211.192, 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.113(b), 211.166(a) |
| Inspection city | Houston |
| Inspection ZIP | 77041 |
| Inspection start date | Nov 9, 2015 |
| 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: