Microtek Dominicana, S.A. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

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.

What these totals cover: FDA records filed under the name "Microtek Dominicana, S.A." and its spelling variant "Microtek Dominicana".

Latest inspection
Aug 16, 2017 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

2 inspections from Jan 29, 2009 to Aug 16, 2017.

DateSiteProductClassificationFEI
Aug 16, 2017La Romana, Dominican Republic (The)DevicesNo Action Indicated (NAI)3003094575
Jan 29, 2009La Romana, Dominican Republic (The)DevicesNo 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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3003094575La Romana, Dominican Republic (The)2Aug 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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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.