483
Codonics IncFDA 483 - Codonics Inc - March 21, 2025
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An FDA inspection of Codonics Inc, a medical device manufacturer in Cleveland, OH, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for complaint handling, risk analysis, document control, and corrective and preventive actions. These issues indicate a systemic breakdown in ensuring product quality and safety.
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ID · 1b9e8955-d038-4c48-bbdb-18602e65a5d2