Warning letter
ProSun International, LLC [ARCHIVED]: warning letter of Aug 15, 2011
FDA warning letter 188053 · Florida District Office
Key facts
| Reference number | 188053 |
|---|---|
| Company | ProSun International, LLC [ARCHIVED] |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Aug 15, 2011 |
| Posted date | Aug 15, 2011 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 1003.10(b), 1040.20(c)(2)(iv), 1004.1(a), 1003.30(a), 1003.11(c), 1003.11(a)(3), 820, 807.81(b), 1002, 1002.13, 1003.20, 1003.21 and 5 more |
| Inspection city | Saint Petersburg |
| Inspection ZIP | 33713 |
| Inspection start date | Mar 9, 2011 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: