Janssen Ortho LLC
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
- United States
- Registered address
- State Road 933 KM 0.1,Mamey Ward, Gurabo, Puerto Rico (PR) 00778, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3002942061 · DUNS 805887986
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-03-28
- VAIDrug Quality Assurance2018-08-28
- VAIDrug Quality Assurance2017-05-26
- VAIDrug Quality Assurance2015-05-29
- VAIBioresearch Monitoring2013-02-22
- VAIDrug Quality Assurance2013-02-22
- VAIDrug Quality Assurance2011-06-13
Drugs this plant is listed as making
14 distinct drugs across 47 products name this site in their FDA label.
- canagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.
- darunavirJanssen Products LP
- DARUNAVIR ETHANOLATE and COBICISTATJanssen Products, LP
- Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LP
- etravirineJanssen Products LP
- ItraconazolePatriot Pharmaceuticals
- Methylphenidate hydrochloridein shortageJanssen Pharmaceuticals, Inc.
- paliperidone palmitateJanssen Pharmaceuticals, Inc
- Pentosan Polysulfate SodiumJanssen Pharmaceuticals, Inc.
- risperidoneJanssen Pharmaceuticals, Inc.
- rivaroxabanJanssen Pharmaceuticals, Inc.
- tapentadol hydrochlorideCollegium Pharmaceutical, Inc.
- topiramateJanssen 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.