483
Next Orthosurgical IncFDA 483 - Next Orthosurgical Inc - August 09, 2024
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An FDA inspection of Next Orthosurgical Inc, a medical device manufacturer in Vista, CA, revealed three significant quality system deficiencies. The firm failed to adequately document process validation activities, maintain and revise device master records, and establish procedures for valid statistical techniques in quality control. These issues indicate a need for improved adherence to regulatory requirements for medical device manufacturing.
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