Janssen-Cilag Manufacturing, 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
- analysismanufacturepack
- FDA identifiers
- FEI 3006244497 · DUNS 963971374
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2026-02-11
- VAIDrug Quality Assurance2021-11-23
- VAIDrug Quality Assurance2017-08-07
- NAIDrug Quality Assurance2013-10-23
- NAIDrug Quality Assurance2011-02-18
- VAIDrug Quality Assurance2009-12-16
Drugs this plant is listed as making
4 distinct drugs across 13 products name this site in their FDA label.
- InfliximabJanssen Biotech, Inc.
- Methylphenidate hydrochloridein shortageJanssen Pharmaceuticals, Inc.
- paliperidoneJanssen Pharmaceuticals, Inc.
- paliperidone palmitateJanssen 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.