FDA 483 - Nelson Laboratories Fairfield, Inc. - April 05, 2023

Nelson Laboratories Fairfield, Inc. in Fairfield, NJ, a contract testing laboratory, received a Form 483 with three observations related to significant deficiencies in its quality control unit and laboratory controls. The firm failed to ensure its quality unit had proper authority and review responsibilities, exhibited a systemic failure to timely close quality events like deviations and CAPAs, and maintained deficient growth promotion procedures for media testing. These issues indicate a lack of adequate control over critical laboratory operations and quality management systems.