Cermaq Chile S.A. No. 10195 FDA Record
Cermaq Chile S.A. No. 10195 has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Cermaq Chile S.A. No. 10195, the most recent on Aug 25, 2017.
- Latest inspection
- Jun 6, 2017 · VAI
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 | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Cermaq Chile S.A. No. 10195 FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Aug 25, 2017 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 6, 2017 | Ancud, Chile | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3004249632 |
| May 15, 2013 | Ancud, Chile | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3004249632 |
| Nov 11, 2011 | Ancud, Chile | Food/Cosmetics | Official Action Indicated (OAI) | 3004249632 |
- 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 Cermaq Chile S.A. No. 10195: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004249632 | Ancud, Chile | 3 | Jun 6, 2017 |
Cermaq Chile S.A. No. 10195 and the FDA: common questions
Has Cermaq Chile S.A. No. 10195 received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Cermaq Chile S.A. No. 10195. The most recent is dated Aug 25, 2017.
Has Cermaq Chile S.A. No. 10195 received an FDA Form 483?
FDA has not published a Form 483 for "Cermaq Chile S.A. No. 10195" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Cermaq Chile S.A. No. 10195?
The most recent FDA inspection on file ended Jun 6, 2017 at Ancud, Chile and was classified VAI. FDA has 3 inspections of Cermaq Chile S.A. No. 10195 on file, 1 of them classified OAI (official action indicated).
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