The warning letter focuses on the inadequacy of specific medical device quality system requirements at the Northridge facility in the areas of risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events. ![]() The warning letter was issued following an inspection that concluded in July 2021 related to recalls of the MiniMed™ 600 series insulin infusion pump, and a remote controller device for MiniMed™ 508 and Paradigm™ pumps. The FDA has not yet released the actual letter, but according to the press release by Medtronic, The company disclosed the letter on December 15th, and shares dropped further. Medtronic received an FDA warning letter on December 9th, 2021, about its diabetes business.
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