Moderna US Inc. FDA Record
Moderna US Inc. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Moderna US Inc." is on file.
- Latest inspection
- Mar 11, 2025 · NAI
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 | 1 | 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 |
|---|---|---|---|---|
| Mar 11, 2025 | Cambridge, MA | Biologics | No Action Indicated (NAI) | 3034723791 |
- 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 3034723791 | Cambridge, MA | 1 | Mar 11, 2025 |
Moderna US Inc. and the FDA: common questions
Has Moderna US Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Moderna US Inc." 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 Moderna US Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Moderna US Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Moderna US Inc.?
The most recent FDA inspection on file ended Mar 11, 2025 at Cambridge, MA and was classified NAI. FDA has 1 inspection of Moderna US Inc. on file.
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