PLIVA Hrvatska D.O.O.

FDA Regulatory Profile

PLIVA Hrvatska D.O.O. has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 27, 2023 · 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 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections8Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Teva Pharmaceuticals Usa
Same company group
2810170Sep 29, 2026 (D-0038-2027)
Actavis Pharma
Same company group
1000Mar 16, 2016 (D-1060-2016)
Teva Pharmaceutical Industries
Same company group
10181Oct 20, 2015 (D-0521-2016)
Watson Laboratories
Same company group
220100Jan 15, 2014 (D-1053-2014)
Teva Canada Limited
Same company group
00190—
Teva Branded Pharmaceutical Products R And D
Same company group
00140—
Barr Laboratories
Same company group
00130—
Teva Parenteral Medicines
Same company group
00111—
Teva Womens Health
Same company group
00120—
Teva Puerto Rico
Same company group
0081—
Teva Czech Industries S.R.O
Same company group
0080—
Teva Api India Private
Same company group
0050—

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 27, 2023Zagreb, CroatiaDrugsVoluntary Action Indicated (VAI)3002807904
Nov 27, 2020Zagreb, CroatiaDrugsVoluntary Action Indicated (VAI)3002807904
May 31, 2018Zagreb, CroatiaDrugsVoluntary Action Indicated (VAI)3002807904
Mar 23, 2018Zagreb, CroatiaDrugsVoluntary Action Indicated (VAI)3002807904
Sep 20, 2016Zagreb, CroatiaDrugsVoluntary Action Indicated (VAI)3002807904
Feb 3, 2015Zagreb, CroatiaDrugsNo Action Indicated (NAI)3002807904
Oct 25, 2013Zagreb, CroatiaDrugsVoluntary Action Indicated (VAI)3002807904
Aug 9, 2012Zagreb, CroatiaDrugsNo Action Indicated (NAI)3002807904

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3002807904Zagreb, Croatia8Oct 27, 2023

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