Manufacturing facility
Fresenius Kabi USA, 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
- 3159 Staley Road, Grand Island, New York (NY) 14072, United States (USA)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3001833549 · DUNS 840771732
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-10-13
- VAIDrug Quality Assurance2019-08-12
- NAIBioresearch Monitoring2017-03-30
- VAIDrug Quality Assurance2017-03-30
- VAIDrug Quality Assurance2017-02-01
- VAIDrug Quality Assurance2016-02-04
- VAIDrug Quality Assurance2014-10-24
- OAIDrug Quality Assurance2013-01-11
- VAIDrug Quality Assurance2011-08-29
- OAIDrug Quality Assurance2011-07-08
- VAIDrug Quality Assurance2010-01-13
- VAIDrug Quality Assurance2009-09-17
- NAIDrug Quality Assurance2009-03-05
- NAIDrug Quality Assurance2008-10-31
Drugs this plant is listed as making
71 distinct drugs across 139 products name this site in their FDA label.
- AcyclovirFresenius Kabi USA, LLC
- AdenosineFresenius Kabi USA, LLC
- Amiodarone HydrochlorideFresenius Kabi USA, LLC
- AztreonamFresenius Kabi USA, LLC
- BortezomibFresenius Kabi USA, LLC
- Caffeine CitrateFresenius Kabi USA, LLC
- Calcium GluconateFresenius Kabi USA, LLC
- Caspofungin AcetateFresenius Kabi USA, LLC
- Chlorothiazide SodiumFresenius Kabi USA, LLC
- Cisatracurium BesylateFresenius Kabi USA, LLC
- Dalbavancin HydrochlorideFresenius Kabi USA, LLC
- dexmedetomidine hydrochloridein shortageFresenius Kabi USA, LLC
- DimenhydrinateFresenius Kabi USA, LLC
- Diphenhydramine HydrochlorideFresenius Kabi USA, LLC
- DoxycyclineFresenius Kabi USA, LLC
- Ephedrine SulfateFresenius Kabi USA, LLC
- Esmolol HydrochlorideFresenius Kabi USA, LLC
- Fentanyl Citratein shortageFresenius Kabi USA, LLC
- Fosphenytoin SodiumFresenius Kabi USA, LLC
- Furosemidein shortageFresenius Kabi USA, LLC
- Ganciclovir SodiumFresenius Kabi USA, LLC
- Granisetron HydrochlorideFresenius Kabi USA, LLC
- Heparin Sodiumin shortageFresenius Kabi USA, LLC
- Hydromorphone Hydrochloridein shortageFresenius Kabi USA, LLC
- IndomethacinFresenius Kabi USA, LLC
- ketamine hydrochlorideFresenius Kabi USA, LLC
- Ketorolac Tromethaminein shortageFresenius Kabi USA, LLC
- LacosamideFresenius Kabi USA, LLC
- LevetiracetamFresenius Kabi USA, LLC
- Lidocaine Hydrochloridein shortageFresenius Kabi USA, LLC
- Lidocaine Hydrochloride,epinephrine Bitartratein shortageFresenius Kabi USA, LLC
- Lorazepamin shortageFresenius Kabi USA, LLC
- Magnesium Sulfate HeptahydrateFresenius Kabi USA, LLC
- MannitolFresenius Kabi USA, LLC
- Melphalan HydrochlorideFresenius Kabi USA, LLC
- Metoprolol TartrateFresenius Kabi USA, LLC
- Midazolam Hydrochloridein shortageFresenius Kabi USA, LLC
- Milrinone LactateFresenius Kabi USA, LLC
- Morphine Sulfatein shortageFresenius Kabi USA, LLC
- Neostigmine MethylsulfateFresenius Kabi USA, LLC
- Ondansetron HydrochlorideFresenius Kabi USA, LLC
- OxytocinFresenius Kabi USA, LLC
- Pemetrexed DisodiumFresenius Kabi USA, LLC
- PosaconazoleFresensius Kabi USA, LLC
- Potassium AcetateFresenius Kabi USA, LLC
- Potassium ChlorideFresenius Kabi USA, LLC
- Potassium Phosphate, Monobasic Potassium Phosphate, DibasicFresenius Kabi USA, LLC
- Propranolol Hydrochloridein shortageFresenius Kabi USA, LLC
- Pyridoxine HydrochlorideFresenius Kabi USA, LLC
- Remifentanil Hydrochloridein shortageFresenius Kabi USA, LLC
- Rocuronium Bromidein shortageFresenius Kabi USA, LLC
- RomidepsinFresenius Kabi USA, LLC
- sincalideBracco Diagnostics Inc.
- Sodium Bicarbonatein shortageFresenius Kabi USA, LLC
- Sodium ChlorideFresenius Kabi USA, LLC
- Sodium Phosphate, Monobasic, MonohydrateFresenius Kabi USA, LLC
- sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrousFresenius Kabi USA, LLC
- Sumatriptan SuccinateFresenius Kabi USA, LLC
- Thiamine HydrochlorideFresenius Kabi USA, LLC
- Tobramycin SulfateFresenius Kabi USA, LLC
- Topotecan HydrochlorideFresenius Kabi USA, LLC
- Valproate Sodiumin shortageFresenius Kabi USA, LLC
- Vancomycin HydrochlorideFresenius Kabi USA, LLC
- VasopressinFresenius Kabi USA, LLC
- Waterin shortageFresenius Kabi USA, LLC
- Zinc SulfateFresenius Kabi USA, 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.