483
Advanced Machine, IncFDA 483 - Advanced Machine, Inc - April 18, 2025
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Record Details
Advanced Machine, Inc., a contract manufacturer of Class I and Class II unfinished medical devices in Winchester, TN, was cited for significant deficiencies in its quality system. The inspection revealed failures in establishing and following procedures for corrective and preventive actions, device history records, and employee training. Additionally, the firm failed to make required quality records readily available for FDA review.
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ID · d9226876-b5f4-4e2c-9ace-fd8e82d475eb