FDA 483 - Nelson Laboratories, LLC - July 30, 2025

Nelson Laboratories, LLC received an FDA Form 483 citing multiple deficiencies in their testing and quality control processes for human cells, tissues, and cellular and tissue-based products (HCT/Ps). Observations included improper handling of amended test results, inadequate record-keeping, contamination risks during processing, and failures in environmental control and personnel training. The findings indicate a lack of robust procedures and controls to ensure product quality and prevent the spread of communicable diseases.