FDA Flags Medtronic for Inspection Failures

August 23, 2017

Medtronic failed to inspect incoming deliveries of parts before including them in the production of insulin infusion pumps at the company’s plant in Northridge, California, the FDA said.

The company received shipments of molded polycarbonate sleeves, used to provide spacing between the casing of insulin pumps and their drive motors, since November 2014 and automatically released them uninspected for use in production under the company’s “dock to stock” system, the agency said, in a Form 483 issued following a March inspection.

In addition, a company inspector certified the parts had been inspected on one form and, on another, noted none were, the FDA said.

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