483
Magic Science Supply LLCFDA 483 - Magic Science Supply LLC - March 29, 2019
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Record Details
An FDA inspection of Simple Science, LLC, a medical device manufacturer in Edina, MN, revealed significant deficiencies in its quality system. The firm failed to conduct management reviews and internal quality audits, and lacked adequately established procedures for both quality audits and corrective and preventive actions. These issues indicate a systemic breakdown in maintaining an effective quality management system.
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ID · c4915497-a9f8-4ebf-8f3d-29054171a68c