FDA 483 - ITI Manufacturing, Inc. - June 03, 2026

ITI Manufacturing, Inc. in Sugar Land, TX, a contract manufacturer, received a Form 483 with three observations during an FDA inspection from June 1-3, 2026. The inspection revealed significant deficiencies in the firm's quality management system. Key issues included a lack of documentation for nonconforming products, absence of written quality agreements for outsourced processes, and inadequate internal audit procedures with no audits conducted since 2003.