Sterigenics U.S., 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
- 10811 Withers Cove Park Dr D, Charlotte, North Carolina (NC) 28278-6928, United States (USA)
- Operations here
- sterilize
- FDA identifiers
- FEI 1000219637 · DUNS 883864076
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2025-12-03
- NAIBlood and Blood Products2025-04-08
- NAIHuman Cellular, Tissue, and Gene Therapies2025-04-08
- NAIDrug Quality Assurance2019-08-26
- NAIHuman Cellular, Tissue, and Gene Therapies2017-07-11
- NAIDrug Quality Assurance2014-06-12
- NAIHuman Cellular, Tissue, and Gene Therapies2014-06-12
- NAIDrug Quality Assurance2011-08-12
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- gemcitabine intravesicalJanssen 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.