Amgen Manufacturing Limited 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
- Carr 31 KM 24.6, Juncos, Puerto Rico (PR) 00777, United States (USA)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 1000110364 · DUNS 785800020
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2026-04-27
- VAIDrug Quality Assurance2023-07-05
- VAIDrug Quality Assurance2019-04-11
- VAIDrug Quality Assurance2018-08-06
- VAIDrug Quality Assurance2017-05-10
- VAIDrug Quality Assurance2015-02-11
- VAIDrug Quality Assurance2015-01-23
- VAIDrug Quality Assurance2013-08-15
- VAIDrug Quality Assurance2013-03-29
- VAIDrug Quality Assurance2012-01-06
- NAIDrug Quality Assurance2011-10-27
- VAIDrug Quality Assurance2011-04-29
- VAIDrug Quality Assurance2010-10-01
- VAIDrug Quality Assurance2010-09-03
- NAIDrug Quality Assurance2010-05-27
- VAIDrug Quality Assurance2009-09-11
- VAIPostmarket Surv. and Epidemiology2009-09-11
- NAIDrug Quality Assurance2009-06-12
Drugs this plant is listed as making
4 distinct drugs across 16 products name this site in their FDA label.
- adalimumab-attoAmgen USA Inc.
- eculizumab-aeebAmgen Inc
- ErythropoietinJanssen Products, LP
- etelcalcetideAmgen, 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.