FDA 483 - Nelson Laboratories, LLC - September 26, 2025

Nelson Laboratories, LLC in Itasca, IL, received a Form 483 with four observations during an inspection from September 23-26, 2025. The observations primarily concern significant deficiencies in data integrity practices, including inadequate audit trail verification, non-concurrent data entry, and unmonitored software/hardware failures impacting data generation. Additionally, the firm's stability program for drug products was found to lack proper documentation and control over storage conditions for retained samples.