Teva Pharmaceutical Works Private Limited Company

FDA Regulatory Profile

Teva Pharmaceutical Works Private Limited Company has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Teva Pharmaceutical Works Private Limited Company" and its spelling variants "Teva Pharmaceutical Works Private Limited", "Teva Pharmaceutical Works Private Ltd". Records filed under related names are not included; see Related names.

Latest inspection
Apr 23, 2026 · VAI

Newer recall under related name Teva Pharmaceuticals Usa: Sep 29, 2026, D-0038-2027.

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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
Inspections4Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

4 inspections from Mar 19, 2012 to Apr 23, 2026.

DateSiteProductClassificationFEI
Apr 23, 2026Debrecen, HungaryDrugsVoluntary Action Indicated (VAI)3031555846
Jan 29, 2016Godollo, HungaryDrugsOfficial Action Indicated (OAI)3002875215
May 13, 2014Godollo, HungaryDrugsNo Action Indicated (NAI)3002875215
Mar 19, 2012Godollo, HungaryDrugsNo Action Indicated (NAI)3002875215
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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Teva Pharmaceutical Works Private Limited Company: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 13, 2016.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3031555846Debrecen, Hungary1Apr 23, 2026
FEI 3002875215Godollo, Hungary3Jan 29, 2016

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