Warning letter
Promise Pharmacy, LLC: warning letter of Jul 29, 2019
FDA warning letter 587148 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 587148 |
|---|---|
| Company | Promise Pharmacy, LLC |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Jul 29, 2019 |
| Posted date | Aug 20, 2019 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 201.115, 200.10(b), 210.1(b) |
| Inspection city | Palm Harbor |
| Inspection ZIP | 34684 |
| Inspection start date | Oct 15, 2018 |
| 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: