FDA 483 - NG Instruments, Inc. - December 14, 2023

An FDA inspection of NG Instruments, Inc., a contract manufacturer in Warsaw, IN, revealed three significant observations, all of which were repeats from previous inspections. The firm failed to adequately establish procedures for controlling nonconforming product, validate processes whose results cannot be fully verified, and establish adequate procedures for the acceptance of in-process product. These issues indicate systemic problems in their quality management system.