Warning letter
ProSun International, LLC: warning letter of Oct 25, 2017
FDA warning letter 539273 · Florida District Office
Key facts
| Reference number | 539273 |
|---|---|
| Company | ProSun International, LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Oct 25, 2017 |
| Posted date | Nov 14, 2017 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 806.10, 803, 806, 820, 820.40 |
| Inspection city | Saint Petersburg |
| Inspection ZIP | 33713 |
| Inspection start date | Aug 1, 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: