FDA 483 - Nelson Environmental Technologies, Inc. - January 24, 2022

Nelson Environmental Technologies, Inc., a medical device manufacturer in Stafford, TX, was inspected by the FDA, revealing significant deficiencies in its quality system. The inspection identified inadequate procedures across multiple areas, including corrective and preventive actions, process validation, incoming product acceptance, and equipment calibration. A repeat observation highlighted the firm's failure to develop and implement adequate electronic Medical Device Reporting procedures.