Exela Pharma Sciences, 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
- 1245 Blowing Rock Blvd. 1325 William White Place 320 Cooperative Way 2101 Morganton Blvd 1201 Exela Way 1170 West Ave NW, Lenoir, North Carolina (NC) 28645, United States (USA)
- Operations here
- analysisapi manufacturelabelmanufacturepacksterilize
- FDA identifiers
- FEI 3008563008 · DUNS 831274399
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 13 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 Assurance2024-11-15
- VAIDrug Quality Assurance2019-07-18
- NAIDrug Quality Assurance2018-12-19
- NAIBioresearch Monitoring2018-09-11
- VAIDrug Quality Assurance2017-09-28
- NAIDrug Quality Assurance2016-06-08
- VAIDrug Quality Assurance2014-11-21
- NAIDrug Quality Assurance2014-08-28
- NAIDrug Quality Assurance2013-04-12
- NAIDrug Quality Assurance2012-01-20
- VAIDrug Quality Assurance2011-09-02
- VAIDrug Quality Assurance2010-12-10
Drugs this plant is listed as making
13 distinct drugs across 27 products name this site in their FDA label.
- caffeine citrateExela Pharma Sciences, LLC
- cupric chlorideExela Pharma Sciences, LLC
- Cysteine HydrochlorideExela Pharma Sciences, LLC
- ephedrine sulfateExela Pharma Sciences, LLC
- glycopyrrolateExela Pharma Sciences, LLC
- Neostigmine MethylsulfateExela Pharma Sciences, LLC
- ParicalcitolWest-Ward Pharmaceuticals Corp
- Potassium AcetateExela Pharma Sciences, LLC
- Sodium Bicarbonatein shortageExela Pharma Sciences, LLC
- Sodium NitroprussideExela Pharma Sciences, Llc
- tranexamic acidExela Pharma Sciences, LLC
- Verapamil HydrochlorideExela Pharma Sciences, 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.