FDA 483 - Davryan Laboratories, Inc. - October 11, 2023

An FDA inspection of Davryan Laboratories, Inc. in Porter, IN, conducted from October 10-11, 2023, identified a significant deficiency in the firm's quality system. The company failed to establish adequate procedures for controlling nonconforming Class II finished products. This indicates a lack of proper controls for identifying, documenting, evaluating, segregating, and disposing of products that do not meet specified requirements.