FDA 483 - Freethink Technologies, Inc. - February 21, 2024

Freethink Technologies, Inc. in Branford, CT, a contract laboratory, was inspected by the FDA from February 12-21, 2024. The inspection revealed significant deficiencies in the firm's quality control unit procedures, including inadequate water system monitoring, insufficient stability chamber management, and a lack of a robust Corrective and Preventive Action (CAPA) system. These issues indicate a serious lack of control over critical quality processes.