Aace Pharmaceuticals, 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
- 15 GARDNER ROAD, FAIRFIELD, New Jersey (NJ) 07004, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3013433273 · DUNS 080630748
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 3 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 Assurance2024-11-22
- VAIDrug Quality Assurance2020-08-10
Drugs this plant is listed as making
3 distinct drugs across 6 products name this site in their FDA label.
- butalbital and acetaminophenAarkish Pharmaceuticals NJ Inc.
- methscopolamine bromidei3 Pharmaceuticals, LLC
- metolazoneAarkish Pharmaceuticals NJ 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.