FDA 483 - Nelson Enviromental Technologies, Inc. - October 10, 2023

Nelson Environmental Technologies, Inc., a manufacturer based in Arlington, TX, was inspected by the FDA from October 3 to October 10, 2023. This inspection led to an FDA Form 483, identifying significant issues with the company's quality system, particularly concerning supplier management. The main observation highlighted that procedures for ensuring all purchased or received products and services conform to specified requirements were not adequately established. Specifically, the company's purchasing procedures, including its Approved Supplier List and supplier evaluation forms, lacked clear criteria and processes for evaluating and selecting suppliers, contractors, and consultants. Additionally, these procedures did not specify the frequency for re-evaluating suppliers, and the firm failed to provide documentation of actual supplier evaluations and selections. This indicates non-compliance with federal quality system requirements. Nelson Environmental Technologies is now required to conduct internal self-audits to identify and correct these and any other quality system violations. The company has indicated a commitment to correct the noted deficiencies, requiring the implementation of robust corrective actions to align its supplier management processes with regulatory standards.