RegWardenFDA facility compliance records
Facility

Elite Biomedical Solutions LLC

1 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2015: 1 recalls; 2017: 1 inspections; 2021: 1 inspections; 2024: 1 inspections1201520161201720182019202012021202220231202420252026
  • Recalls (1)
  • Inspections (3)

Devices registered here (1)

Recalls & enforcement

  • Class ITerminated2015-06-03
    Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.

FDA inspections (3)

  • NAI2024-05-10
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • VAI2021-11-09
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2017-04-06
    Voluntary Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Elite Biomedical Solutions LLC (FEI 3009712113) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009712113-elite-biomedical-solutions-llc/

Not open yet

Alerts for Elite Biomedical Solutions LLC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.