ONY Biotech Inc.
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
- 455 Commerce Dr, Amherst, New York (NY) 14228, United States (USA)
- Operations here
- labelpack
- FDA identifiers
- FEI 1319086 · DUNS 119447554
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 1 drugs. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2026-02-05
- OAIDrug Quality Assurance2024-09-26
- NAIBioresearch Monitoring2017-03-02
- VAIDrug Quality Assurance2015-10-09
- NAIDrug Quality Assurance2013-04-25
- NAIPostmarket Surv. and Epidemiology2013-04-25
- VAIDrug Quality Assurance2011-10-06
- NAIDrug Quality Assurance2010-11-09
- NAIDrug Quality Assurance2009-12-03
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- calfactantONY 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.