Warning letter
Belmar Pharma Solutions, Drug Depot, LLC., dba APS Pharmacy: warning letter of Mar 31, 2023
FDA warning letter 653740 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 653740 |
|---|---|
| Company | Belmar Pharma Solutions, Drug Depot, LLC., dba APS Pharmacy |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Mar 31, 2023 |
| Posted date | Apr 18, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 201.115 |
| Inspection city | Palm Harbor |
| Inspection ZIP | 34684 |
| Inspection start date | Jun 6, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- VAI 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: