FDA 483 - Magic Science Supply LLC - August 07, 2025
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Magic Science Supply LLC, a medical device manufacturer in Edina, MN, was cited with four observations during an FDA inspection. The firm's quality system was found to have significant deficiencies, particularly concerning inadequately established procedures for finished device acceptance, corrective and preventive actions, control of non-conforming products, and supplier approval. These issues resulted in the release of products not meeting specifications and a lack of proper controls across critical quality processes.
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ID · 39ba60f8-ca64-41f0-aa1b-9ed613faa92d