Les Emballages Facoteck Inc FDA Record
Les Emballages Facoteck Inc has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Les Emballages Facoteck Inc, the most recent on Aug 21, 2018.
- Latest inspection
- Dec 1, 2017 · OAI
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 | 1 | 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 | 0 | 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 | 1 | 0 | 0 |
| 2017 | 1 | 1 | 0 | 0 | 0 |
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Les Emballages Facoteck Inc FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Aug 21, 2018 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 1, 2017 | Scotstown, Canada | Drugs | Official Action Indicated (OAI) | 3002955163 |
- 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.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Les Emballages Facoteck Inc: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002955163 | Scotstown, Canada | 1 | Dec 1, 2017 |
Les Emballages Facoteck Inc and the FDA: common questions
Has Les Emballages Facoteck Inc received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Les Emballages Facoteck Inc. The most recent is dated Aug 21, 2018.
Has Les Emballages Facoteck Inc received an FDA Form 483?
FDA has not published a Form 483 for "Les Emballages Facoteck Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Les Emballages Facoteck Inc?
The most recent FDA inspection on file ended Dec 1, 2017 at Scotstown, Canada and was classified OAI. FDA has 1 inspection of Les Emballages Facoteck Inc on file, 1 of them classified OAI (official action indicated).
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