483
Advanced Machine, IncFDA 483 - Advanced Machine, Inc - May 02, 2019
Record Details
An FDA inspection of Advanced Machine, Inc. in Winchester, TN, a contract manufacturer, revealed significant deficiencies in their quality management system. Observations included inadequate procedures for equipment calibration, corrective and preventive actions, and customer complaint handling. The firm also failed to adequately maintain records of document changes, indicating systemic issues in their quality processes.
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ID · 60243095-52c6-43ff-a542-70632c8ef303