Productos Roche S.A. De C. V. FDA Record
Productos Roche S.A. De C. V. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Productos Roche S.A. De C. V." is on file.
- Latest inspection
- Mar 3, 2017 · VAI
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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 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 3, 2017 | Toluca De Lerdo, Mexico | Drugs | Voluntary Action Indicated (VAI) | 3003502861 |
| Feb 6, 2015 | Toluca De Lerdo, Mexico | Drugs | Voluntary Action Indicated (VAI) | 3003502861 |
| May 29, 2013 | Toluca De Lerdo, Mexico | Drugs | No Action Indicated (NAI) | 3003502861 |
| Aug 11, 2011 | Toluca De Lerdo, Mexico | Drugs | No Action Indicated (NAI) | 3003502861 |
| Oct 23, 2009 | Toluca De Lerdo, Mexico | Drugs | No Action Indicated (NAI) | 3003502861 |
- 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 3003502861 | Toluca De Lerdo, Mexico | 5 | Mar 3, 2017 |
Productos Roche S.A. De C. V. and the FDA: common questions
Has Productos Roche S.A. De C. V. received an FDA warning letter?
No FDA warning letter addressed to the name "Productos Roche S.A. De C. V." 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 Productos Roche S.A. De C. V. received an FDA Form 483?
FDA has not published a Form 483 for "Productos Roche S.A. De C. V." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Productos Roche S.A. De C. V.?
The most recent FDA inspection on file ended Mar 3, 2017 at Toluca De Lerdo, Mexico and was classified VAI. FDA has 5 inspections of Productos Roche S.A. De C. V. on file.
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