Warning letter
Empower Clinic Services, LLC dba Empower Pharmacy: warning letter of Oct 15, 2021
FDA warning letter 613792 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 613792 |
|---|---|
| Company | Empower Clinic Services, LLC dba Empower Pharmacy |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Oct 15, 2021 |
| Posted date | Oct 26, 2021 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 201.115, 211.198, 310.305(c)(2) |
| Inspection city | Houston |
| Inspection ZIP | 77041 |
| Inspection start date | Feb 12, 2020 |
| 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: