Coopervision Manufacturing Costa Rica SRL FDA Record
- Latest inspection NAI · Apr 27, 2017
- No warning letters matched by name
Coopervision Manufacturing Costa Rica SRL has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Coopervision Manufacturing Costa Rica SRL" is on file.
- Latest recall
- Z-0204-2027 · Sep 22, 2026 · filed under Coopervision
- Latest inspection
- Apr 27, 2017 · NAI
Newer recall under related name Coopervision: Sep 22, 2026, Z-0204-2027.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 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 |
|---|---|---|---|---|
| Apr 27, 2017 | Alajuela, Costa Rica | Devices | No Action Indicated (NAI) | 3012123291 |
- 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 3012123291 | Alajuela, Costa Rica | 1 | Apr 27, 2017 |
Coopervision Manufacturing Costa Rica SRL and the FDA: common questions
Has Coopervision Manufacturing Costa Rica SRL received an FDA warning letter?
No FDA warning letter addressed to the name "Coopervision Manufacturing Costa Rica SRL" 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 Coopervision Manufacturing Costa Rica SRL received an FDA Form 483?
FDA has not published a Form 483 for "Coopervision Manufacturing Costa Rica SRL" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Coopervision Manufacturing Costa Rica SRL?
The most recent FDA inspection on file ended Apr 27, 2017 at Alajuela, Costa Rica and was classified NAI. FDA has 1 inspection of Coopervision Manufacturing Costa Rica SRL on file.
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