RegWardenFDA facility compliance records
Facility

THE METRIX COMPANY

4 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2016: 1 recalls, 1 inspections; 2017: 1 recalls; 2018: 1 recalls; 2019: 1 inspections; 2024: 1 recalls2201612017120181201920202021202220231202420252026
  • Recalls (4)
  • Inspections (2)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2024-10-09
    A limited number of IV bags have been found to leak during filling.
  • Class IIOngoing2018-09-21
    Potential for leaking product
  • Class IITerminated2017-09-13
    The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.
  • Class IITerminated2016-06-23
    An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly…

FDA inspections (2)

  • VAI2019-04-25
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • VAI2016-05-06
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: 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. “THE METRIX COMPANY (FEI 1000117446) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000117446-the-metrix-company/

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