Liebel-Flarsheim Company 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
- 8800 Durant Road, Raleigh, North Carolina (NC) 27616, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 1028892 · DUNS 109024984
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 8 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 Assurance2025-04-08
- NAIDrug Quality Assurance2018-08-31
- NAIDrug Quality Assurance2016-07-29
- NAIDrug Quality Assurance2014-07-25
- NAIDrug Quality Assurance2012-05-04
- VAIDrug Quality Assurance2010-08-20
- NAIDrug Quality Assurance2010-03-05
Drugs this plant is listed as making
8 distinct drugs across 23 products name this site in their FDA label.
- diatrizoate meglumine and diatrizoate sodiumLiebel-Flarsheim Company LLC
- GadopiclenolBracco Diagnostics Inc
- gadoterate meglumineGuerbet LLC
- Iothalamate meglumineLiebel-Flarsheim Company LLC
- IoversolLiebel-Flarsheim Company LLC
- sodium chlorideLiebel-Flarsheim Company LLC
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.