FDA 483 - Trident Manufacturing, Inc. - August 28, 2025

An FDA inspection of Trident Manufacturing, Inc. in Pingree Grove, IL, revealed significant deficiencies in the firm's quality system. Observations included inadequate procedures for controlling non-conforming product, insufficient complaint handling processes, and a lack of executive approval for the quality policy and objectives. These issues highlight a need for improved documentation, execution, and management oversight within the firm's quality management system.