GE Healthcare (Shanghai) Co Ltd.
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
- China
- Registered address
- No. 1 Niudun Road, China (Shanghai) Pilot Free Trade Zone, Shanghai 201203, China (CHN)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3005292384 · DUNS 545292716
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-10-30
- VAIDrug Quality Assurance2018-05-10
- VAIDrug Quality Assurance2016-08-12
- VAIDrug Quality Assurance2013-11-08
- NAIDrug Quality Assurance2011-04-15
- VAIDrug Quality Assurance2008-10-17
Drugs this plant is listed as making
4 distinct drugs across 7 products name this site in their FDA label.
- gadodiamideGE Healthcare Inc.
- gadoterate meglumineGE Healthcare
- IodixanolGE Healthcare Inc.
- IohexolGE Healthcare 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.