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Casco Manufacturing Solutions landed a Form 483 from the FDA for problems with device master records, document control procedures and equipment maintenance. Read More
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. Read More
The findings concerning supplier requirements and design-change procedures were repetitions of inspection results from 2009 and 2014, the FDA said. Read More