SMC Costa Rica Division S.R.L. FDA Record
SMC Costa Rica Division S.R.L. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "SMC Costa Rica Division S.R.L." is on file.
- Latest inspection
- Oct 20, 2016 · NAI
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 | 2 | Nov 14, 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 |
|---|---|---|---|---|
| Oct 20, 2016 | El Coyol, Costa Rica | Devices | No Action Indicated (NAI) | 3009327445 |
| Feb 27, 2013 | El Coyol, Costa Rica | Devices | No Action Indicated (NAI) | 3009327445 |
- 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 3009327445 | El Coyol, Costa Rica | 2 | Oct 20, 2016 |
SMC Costa Rica Division S.R.L. and the FDA: common questions
Has SMC Costa Rica Division S.R.L. received an FDA warning letter?
No FDA warning letter addressed to the name "SMC Costa Rica Division S.R.L." 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 SMC Costa Rica Division S.R.L. received an FDA Form 483?
FDA has not published a Form 483 for "SMC Costa Rica Division S.R.L." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect SMC Costa Rica Division S.R.L.?
The most recent FDA inspection on file ended Oct 20, 2016 at El Coyol, Costa Rica and was classified NAI. FDA has 2 inspections of SMC Costa Rica Division S.R.L. on file.
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