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

Nelson Environmental Technologies, Inc., a medical device manufacturer in Stafford, TX, was inspected and cited for multiple quality system deficiencies. The inspection revealed inadequate procedures for corrective and preventive actions, process validation, incoming product acceptance, risk analysis, equipment calibration, process controls, purchasing data, nonconforming product disposition, and quality audits. Additionally, the firm's Medical Device Reporting (MDR) procedures were found to be outdated and insufficient, a repeat observation.