Flamma USA LLC FDA Record
- Latest inspection VAI · Oct 24, 2025
- No warning letters matched by name
Flamma USA LLC has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Flamma USA LLC" is on file.
- Latest inspection
- Oct 24, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 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 |
|---|---|---|---|---|
| Oct 24, 2025 | Malvern, PA | Drugs | Voluntary Action Indicated (VAI) | 3016004065 |
- 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 3016004065 | Malvern, PA | 1 | Oct 24, 2025 |
Flamma USA LLC and the FDA: common questions
Has Flamma USA LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Flamma USA LLC" 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 Flamma USA LLC received an FDA Form 483?
FDA has not published a Form 483 for "Flamma USA LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Flamma USA LLC?
The most recent FDA inspection on file ended Oct 24, 2025 at Malvern, PA and was classified VAI. FDA has 1 inspection of Flamma USA LLC on file.
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