Unither Manufacturing 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
- 755 Jefferson Rd., Rochester, New York (NY) 14623, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 1314625 · DUNS 079176615
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 4 drugs, 1 already in shortage. 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 Assurance2026-05-15
- VAIDrug Quality Assurance2021-10-15
- VAIDrug Quality Assurance2019-05-22
- VAIDrug Quality Assurance2017-03-01
- NAIDrug Quality Assurance2015-06-01
- VAIDrug Quality Assurance2012-06-15
- VAIDrug Quality Assurance2010-11-23
- NAIDrug Quality Assurance2010-01-19
Drugs this plant is listed as making
4 distinct drugs across 19 products name this site in their FDA label.
- Atropine Sulfatein shortageBausch & Lomb Incorporated
- certolizumab pegolUCB, Inc.
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz Inc
- Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, 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.