483
SM Worldwide USA, Inc.FDA 483 - SM Worldwide USA, Inc. - February 05, 2020
Record Details
An FDA inspection of GM Worldwide USA, Inc., a medical device importer in Jamaica, NY, revealed significant deficiencies in their quality system. The firm was cited for failing to establish written procedures for Medical Device Reporting (MDR), complaint handling, and corrective and preventive actions (CAPA). These observations indicate a fundamental lack of critical operational controls.
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