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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
A Florida hearing-aid manufacturer drew the FDA’s attention for various deficiencies observed during a May inspection, including inadequate procedures for responding to problems and complaints. Read More