Quinta-Analytica s.r.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
- Czech Republic
- Registered address
- Prazska 1486/18c, Prague 10, 10200, Czech Republic (CZE)
- Operations here
- analysis
- FDA identifiers
- FEI 3005363495 · DUNS 495722555
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-03-06
- VAIBioresearch Monitoring2025-01-10
- VAIBioresearch Monitoring2022-11-03
- VAIDrug Quality Assurance2021-04-20
- VAIDrug Quality Assurance2019-01-16
- VAIDrug Quality Assurance2016-02-05
- NAIDrug Quality Assurance2013-03-27
- NAIDrug Quality Assurance2009-06-02
Drugs this plant is listed as making
2 distinct drugs across 2 products name this site in their FDA label.
- darolutamideBayer HealthCare Pharmaceuticals Inc.
- elafibranorIpsen Biopharmaceuticals, Inc.
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.