DGI Group LLC – FDA 483, Aug 19, 2025

An FDA inspection of DGI Group LLC, a manufacturing firm located in Howell, NJ, was conducted from August 4 to August 19, 2025. The inspection identified several critical deficiencies in the company's design control processes for its Claritag devices, leading to the issuance of a Form FDA-483.

The main violations concerned the inadequate establishment and implementation of quality system requirements, specifically regarding design control. Key issues included insufficient procedures for design validation, with a lack of documentation for accelerated and real-time aging tests and missing stability reports for Claritag devices. Design verification processes failed to ensure that design outputs met input requirements, and design outputs for Claritag Rx and Claritag Advanced devices were not adequately documented prior to release, often relying on generalized references.

Additionally, design review procedures were found deficient, with only a final design review documented instead of periodic reviews at major development stages. Design plans for the Claritag device development were inadequately established, missing essential elements like design inputs, outputs, tasks, testing, risk assessment, and verification activities.

These observations indicate a need for DGI Group LLC to enhance its adherence to the Federal Food, Drug, and Cosmetic Act's quality system regulations. The company is responsible for implementing comprehensive corrective actions to address these violations, which it "Promised to correct" during the inspection.