FDA 483 - Integra LifeSciences Corporation - June 05, 2024
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An FDA inspection of Integra LifeSciences Corporation revealed significant deficiencies in quality control and manufacturing processes. The firm released medical devices despite out-of-specification endotoxin results and failed to adequately investigate environmental contamination in its cleanroom. Additionally, issues were noted in process validation, CAPA management, storage area controls, and finished device acceptance procedures, indicating a systemic lack of adherence to quality system regulations.
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