RegWardenFDA facility compliance records
Facility

TERRIFIC CARE LLC

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

Activity by year

FDA actions on record by year2018: 1 recalls; 2019: 1 inspections; 2021: 1 inspections2017120181201920201202120222023202420252026
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

  • Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase
    Product code JNE (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1570

Recalls & enforcement

  • Class ITerminated2018-12-20
    Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customers who purchased products directly from Terrific Care LLC dba MedEx Supply via website/telephone/facsimile.

FDA inspections (2)

  • NAI2021-05-27
    No Action Indicated · Compliance: Devices
  • VAI2019-02-05
    Voluntary Action Indicated · Compliance: Devices · citations posted

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. “TERRIFIC CARE LLC (FEI 3014100519) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014100519-terrific-care-llc/

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