Roche Products FDA Record
Roche Products has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Roche Products" is on file.
- Latest recall
- Z-2951-2026 · Jun 10, 2026 · filed under Foundation Medicine
- Latest inspection
- Jul 30, 2009 · NAI
Newer recall under related name Foundation Medicine: Jun 10, 2026, Z-2951-2026.
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 |
|---|---|---|---|---|
| Jul 30, 2009 | Welwyn Garden City, United Kingdom | Drugs | No Action Indicated (NAI) | 3002808030 |
- 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 3002808030 | Welwyn Garden City, United Kingdom | 1 | Jul 30, 2009 |
Roche Products and the FDA: common questions
Has Roche Products received an FDA warning letter?
No FDA warning letter addressed to the name "Roche Products" 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 Roche Products received an FDA Form 483?
FDA has not published a Form 483 for "Roche Products" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Roche Products?
The most recent FDA inspection on file ended Jul 30, 2009 at Welwyn Garden City, United Kingdom and was classified NAI. FDA has 1 inspection of Roche Products on file.
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