483
Structure Medical, LLCFDA 483 - Structure Medical, LLC - March 03, 2017
Record Details
Structure Medical, LLC, a medical device contract manufacturer in Naples, FL, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, rework documentation, acceptance activities, and internal quality audits. These issues indicate a lack of robust controls to ensure product quality and compliance with regulatory requirements.
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ID · 81fa3af0-78c7-4259-8964-2aebe1da7d8a