FDA 483 - Arthrex, Inc. - May 05, 2023
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An FDA inspection of Arthrex, Inc. in Naples, FL, revealed significant deficiencies in their quality system. The firm was cited for failing to adequately establish and implement procedures for receiving, reviewing, and evaluating complaints, leading to inconsistent application of complaint definitions and inadequate investigations. Additionally, the inspection found that written Medical Device Report (MDR) procedures were not adequately implemented, resulting in untimely reporting of reportable events and failure to report certain malfunctions.
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