FDA 483 - Medtronic Neuromodulation - June 15, 2006
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An FDA inspection of Medtronic Neurological in Minneapolis, MN, revealed significant deficiencies in their quality system related to medical device manufacturing. The firm failed to adequately implement procedures for design input, design validation, and process validation for their 8731 Intrathecal Catheters. Additionally, issues were found in production process control, the effectiveness of corrective and preventive actions, maintenance of device history records, and the completeness of medical device reports.
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