RegWardenFDA facility compliance records
Facility

RAND S.p.A.

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

Activity by year

FDA actions on record by year2021: 1 recalls; 2023: 1 inspections201720182019202012021202212023202420252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

  • Class IITerminated2021-04-30
    The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.

FDA inspections (1)

  • NAI2023-02-16
    No Action Indicated · Compliance: Devices; Postmarket Assurance: 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. “RAND S.p.A. (FEI 3003793891) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003793891-rand-s-p-a/

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