Stoney Marine International FDA Record
Stoney Marine International has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Stoney Marine International" is on file.
- Latest inspection
- May 21, 2019 · OAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 5 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 21, 2019 | Charleston, SC | Food/Cosmetics | Official Action Indicated (OAI) | 1038478 |
| Feb 21, 2014 | Charleston, SC | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1038478 |
| Mar 29, 2011 | Charleston, SC | Food/Cosmetics | No Action Indicated (NAI) | 1038478 |
| Jun 7, 2010 | Charleston, SC | Food/Cosmetics | No Action Indicated (NAI) | 1038478 |
| Mar 17, 2009 | Charleston, SC | Food/Cosmetics | No Action Indicated (NAI) | 1038478 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1038478 | Charleston, SC | 5 | May 21, 2019 |
Stoney Marine International and the FDA: common questions
Has Stoney Marine International received an FDA warning letter?
No FDA warning letter addressed to the name "Stoney Marine International" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Stoney Marine International received an FDA Form 483?
FDA has not published a Form 483 for "Stoney Marine International" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Stoney Marine International?
The most recent FDA inspection on file ended May 21, 2019 at Charleston, SC and was classified OAI. FDA has 5 inspections of Stoney Marine International on file, 1 of them classified OAI (official action indicated).
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