Rolabo Outsourcing S.L.
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
- Spain
- Registered address
- Poligono Industrial Malpica, Calle J, Parcelas 3-4, Zaragoza, 50016, Spain (ESP)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3003688035 · DUNS 513603225
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-12-21
- VAIDrug Quality Assurance2020-10-29
- NAIDrug Quality Assurance2018-09-07
- VAIDrug Quality Assurance2016-01-21
- NAIDrug Quality Assurance2014-02-06
- VAIDrug Quality Assurance2011-07-28
Drugs this plant is listed as making
1 distinct drugs across 4 products name this site in their FDA label.
- canagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, 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.