FDA 483 - G21 USA, Inc. - July 25, 2023

On July 24-25, 2023, FDA investigators Colin E Tack and Tanvir Kaium inspected G21 USA, Inc., an initial importer located at 120 E 73rd St, Suite 3B, New York, NY 10021. The inspection resulted in a Form FDA 483 being issued to CEO Maurizio Foroni, detailing three observations.

Observation 1 noted that procedures for receiving, reviewing, and evaluating complaints were not adequately established. Specifically, the firm could not provide complaint files/logs, and their draft "CUSTOMER SERVICE PROCEDURE, Rev 00" lacked a definition of a complaint.

Observation 2 indicated that procedures for corrective and preventive action had not been established, as the firm was unable to provide such procedures.

Observation 3 stated that procedures for training and identifying training needs had not been established. The firm could not provide a personnel training procedure, and training documentation was absent for personnel involved in incoming inspection of finished products and customer complaint handling.

For all three observations, the firm "Promised to correct." This document serves as inspectional observations and not a final agency determination of compliance.