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# Issues in Medtronic Northridge Inspection
- URL: https://www.fdaweb.com/issues-in-medtronic-northridge-inspection/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:26:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150825

A 6/7/21-7/7/21 FDA inspection at the Medtronic facility in Northridge, CA, found Quality System Regulation and Medical Device Reporting violations in the firm’s work manufacturing the MiniMed 600 series insulin infusion pumps and software and remote controllers used with the Paradigm and MiniMed series insulin infusion pumps. A 12/9/21 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medtronic-inc-617539-12092021?ref=fdaweb.com) says specific violations were: 

- failing to adequately establish procedures for corrective and preventive action;
- failing to review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications;
- failing to submit a report to FDA no later than 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury; and
- failing to submit a report to FDA no later than 30 calendar days after the day the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that the firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Medtronic was told to schedule a teleconference with FDA to further discuss its response to the Warning Letter and to also respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the corrections or corrective actions and a timetable for completing the work.