Microtek Dominicana, S.A. FDA Record
Microtek Dominicana, S.A. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Microtek Dominicana, S.A." is on file.
- Latest inspection
- Aug 16, 2017 · NAI
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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 | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 16, 2017 | La Romana, Dominican Republic (The) | Devices | No Action Indicated (NAI) | 3003094575 |
| Jan 29, 2009 | La Romana, Dominican Republic (The) | Devices | No Action Indicated (NAI) | 3003094575 |
- 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 3003094575 | La Romana, Dominican Republic (The) | 2 | Aug 16, 2017 |
Microtek Dominicana, S.A. and the FDA: common questions
Has Microtek Dominicana, S.A. received an FDA warning letter?
No FDA warning letter addressed to the name "Microtek Dominicana, S.A." 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 Microtek Dominicana, S.A. received an FDA Form 483?
FDA has not published a Form 483 for "Microtek Dominicana, S.A." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Microtek Dominicana, S.A.?
The most recent FDA inspection on file ended Aug 16, 2017 at La Romana, Dominican Republic (The) and was classified NAI. FDA has 2 inspections of Microtek Dominicana, S.A. on file.
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