Fersinsa GB, SA De CV FDA Record
Fersinsa GB, SA De CV has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Fersinsa GB, SA De CV" is on file.
- Latest inspection
- Sep 23, 2022 · 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 |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 23, 2022 | Ramos Arizpe, Mexico | Drugs | Voluntary Action Indicated (VAI) | 3000538793 |
| Jun 13, 2017 | Ramos Arizpe, Mexico | Drugs | No Action Indicated (NAI) | 3000538793 |
| Sep 10, 2014 | Ramos Arizpe, Mexico | Drugs | Voluntary Action Indicated (VAI) | 3000538793 |
| Jan 19, 2009 | Ramos Arizpe, Mexico | Drugs | Voluntary Action Indicated (VAI) | 3000538793 |
| Jan 19, 2009 | Ramos Arizpe, Mexico | Drugs | Voluntary Action Indicated (VAI) | 3000538793 |
- 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 3000538793 | Ramos Arizpe, Mexico | 5 | Sep 23, 2022 |
Fersinsa GB, SA De CV and the FDA: common questions
Has Fersinsa GB, SA De CV received an FDA warning letter?
No FDA warning letter addressed to the name "Fersinsa GB, SA De CV" 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 Fersinsa GB, SA De CV received an FDA Form 483?
FDA has not published a Form 483 for "Fersinsa GB, SA De CV" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Fersinsa GB, SA De CV?
The most recent FDA inspection on file ended Sep 23, 2022 at Ramos Arizpe, Mexico and was classified VAI. FDA has 5 inspections of Fersinsa GB, SA De CV on file.
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