RegWardenFDA facility compliance records
Facility

Intrinsic Therapeutics, Inc.

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

Activity by year

FDA actions on record by year2017: 2 inspections; 2020: 1 recalls; 2022: 1 inspections; 2024: 1 recalls; 2025: 1 inspections220172018201912020202112022202312024120252026
  • Recalls (2)
  • Inspections (4)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2024-07-25
    At least two units have been found to be missing a weld.
  • Class IITerminated2020-07-24
    The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner container (box) is incorrect. It states BAR-A8-10MM instead of BAR-A8-8MM.

FDA inspections (4)

  • NAI2025-09-26
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • VAI2022-07-21
    Voluntary Action Indicated · Compliance: Devices · citations posted
  • NAI2017-09-29
    No Action Indicated · Compliance: Devices
  • NAI2017-03-31
    No Action Indicated · Bioresearch Monitoring

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. “Intrinsic Therapeutics, Inc. (FEI 3006232063) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006232063-intrinsic-therapeutics-inc/

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