Przedsiebiorstwo Farmaceutyczne Jelfa S.A.
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
- Poland
- Registered address
- ul. Wincentego Pola 21, Jelenia Gora, 58-500, Poland (POL)
- Operations here
- manufacture
- FDA identifiers
- FEI 3004680543 · DUNS 366616639
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-11-25
- NAIDrug Quality Assurance2018-03-13
- VAIDrug Quality Assurance2016-09-22
- NAIDrug Quality Assurance2014-06-30
- VAIDrug Quality Assurance2012-05-15
- OAIDrug Quality Assurance2010-10-22
Drugs this plant is listed as making
2 distinct drugs across 2 products name this site in their FDA label.
- Methylergonovine MaleateBreckenridge Pharmaceutical, 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.