Gateway Analytical, 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
- 2009 Kramer Road, Gibsonia, Pennsylvania (PA) 15044, United States (USA)
- Operations here
- analysis
- FDA identifiers
- FEI 3009255642 · DUNS 047276968
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2026-03-20
- NAIDrug Quality Assurance2022-09-16
- NAIDrug Quality Assurance2015-01-15
- NAIDrug Quality Assurance2012-11-05
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- HydrocortisoneEton 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.