Simtra US 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
- 927 South Curry Pike, Bloomington, Indiana (IN) 47403, United States (USA)
- Operations here
- analysislabelmanufacturepackrelabelsterilize
- FDA identifiers
- FEI 1000115571 · DUNS 604719430
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-09-24
- NAIDrug Quality Assurance2023-02-17
- VAIVaccines and Allergenic Products2021-11-10
- VAIBlood and Blood Products2018-05-23
- VAIVaccines and Allergenic Products2018-05-23
- VAIDrug Quality Assurance2017-07-17
- VAIBlood and Blood Products2016-05-12
- VAIVaccines and Allergenic Products2016-05-12
- VAIDrug Quality Assurance2014-10-24
- NAIDrug Quality Assurance2014-05-02
- VAIDrug Quality Assurance2013-05-10
- VAIDrug Quality Assurance2013-03-12
- VAIDrug Quality Assurance2012-09-27
- NAIDrug Quality Assurance2011-08-16
- NAIVaccines and Allergenic Products2011-06-17
- VAIDrug Quality Assurance2011-03-25
- VAIDrug Quality Assurance2010-09-23
- VAIBlood and Blood Products2010-03-24
- VAIVaccines and Allergenic Products2010-03-24
- NAIDrug Quality Assurance2009-10-30
Drugs this plant is listed as making
4 distinct drugs across 7 products name this site in their FDA label.
- DaratumumabJanssen Biotech, Inc.
- golimumabJanssen Biotech, Inc.
- regadenosonBaxter Healthcare Corporation
- ustekinumabJanssen Biotech, 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.