FDA 483 - Horizon Scientific - April 18, 2025
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An FDA inspection of Horizon Scientific in Summerville, SC, revealed three significant observations related to their quality system. The firm failed to establish adequate procedures for servicing activities, lacked signed agreements with suppliers and contractors, and had insufficient document control procedures, including listing an incorrect user manual revision in device history records. These findings indicate deficiencies in maintaining a compliant quality management system.
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ID · a543dc42-660e-4727-a09e-c0c49b1035fd