Deva Holding A.S. - Kartepe Uretim Tesisleri FDA Record

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

Deva Holding A.S. - Kartepe Uretim Tesisleri has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Deva Holding A.S. - Kartepe Uretim Tesisleri" is on file.

What these totals cover: FDA records filed under the name "Deva Holding A.S. - Kartepe Uretim Tesisleri".

Latest inspection
Dec 6, 2023 · NAI

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
Inspections3Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

3 inspections from Jul 30, 2015 to Dec 6, 2023.

DateSiteProductClassificationFEI
Dec 6, 2023Kartepe, TurkeyDrugsNo Action Indicated (NAI)3008966143
Jul 25, 2023Kartepe, TurkeyDrugsVoluntary Action Indicated (VAI)3008966143
Jul 30, 2015Kartepe, TurkeyDrugsVoluntary Action Indicated (VAI)3008966143
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 3008966143Kartepe, Turkey3Dec 6, 2023

Deva Holding A.S. - Kartepe Uretim Tesisleri and the FDA: common questions

Has Deva Holding A.S. - Kartepe Uretim Tesisleri received an FDA warning letter?

No FDA warning letter addressed to the name "Deva Holding A.S. - Kartepe Uretim Tesisleri" 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 Deva Holding A.S. - Kartepe Uretim Tesisleri received an FDA Form 483?

FDA has not published a Form 483 for "Deva Holding A.S. - Kartepe Uretim Tesisleri" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Deva Holding A.S. - Kartepe Uretim Tesisleri?

The most recent FDA inspection on file ended Dec 6, 2023 at Kartepe, Turkey and was classified NAI. FDA has 3 inspections of Deva Holding A.S. - Kartepe Uretim Tesisleri on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.