483
Nelson Enviromental Technologies, Inc.FDA 483 - Nelson Enviromental Technologies, Inc. - June 18, 2025
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Record Details
An FDA inspection of Nelson Enviromental Technologies, Inc. in Arlington, TX, revealed significant deficiencies in their quality management system. Observations included inadequate corrective and preventive action procedures, insufficient sampling methods for Class II devices, and incomplete device history records. Additionally, the firm failed to appoint a management representative to oversee quality system requirements.
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ID · 3d0ef10a-bd4e-4c6f-bb7a-27d4a65827ca