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.
Similar dock-to-stock treatment was accorded to other lots of items repackaged and relabeled by Medtronic for infusion-pump production. The facility also received 100 spools of spring wire and sampled just one for inspection, 12 short of the required number, the agency said.
The company also could not find one lot of infusion pump belt clips that its tracking system said was awaiting inspection. Initially, the company said the clips had been moved to production. Later, it said they were included in an engineering evaluation, but there were no supporting records.
Medtronic also failed to establish adequate procedures for storing materials and equipment, mingling parts headed to the scrap heap with others approved for use, the agency said.