FDA 483 - Nelson Laboratories, LLC - June 02, 2023

Nelson Laboratories, LLC, a laboratory in Salt Lake City, UT, was cited for failing to establish the accuracy and sensitivity of its test methods. Specifically, the firm produced media for testing using cycle times outside of its validated process, with over 400 such occurrences since 2018, and failed to revalidate or trend these excursions. This indicates significant issues with process validation and quality control for sterility testing media.