Pliva Hrvatska d.o.o.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Croatia
- Registered address
- Prilaz Baruna Filipovica 25, Zagreb, 10000, Croatia (HRV)
- Operations here
- analysislabelmanufacturepackrepacksterilize
- FDA identifiers
- FEI 3002807904 · DUNS 499659316
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-10-27
- VAIDrug Quality Assurance2020-11-27
- VAIBioresearch Monitoring2018-05-31
- VAIDrug Quality Assurance2018-03-23
- VAIDrug Quality Assurance2016-09-20
- NAIDrug Quality Assurance2015-02-03
- VAIDrug Quality Assurance2013-10-25
- NAIDrug Quality Assurance2012-08-09
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- Metronidazolein shortageUpsher-smith Laboratories, LLC
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.