FDA 483 - Clearwater Colon Hydrotherapy, Inc. - March 26, 2026

Clearwater Colon Hydrotherapy, Inc. in Ocala, FL, a medical device manufacturer, received a Form FDA 483 with six observations during an inspection from March 24-26, 2026. The observations highlight significant deficiencies in their quality management system, including inadequate documentation, lack of process validation, and insufficient design and document control. These issues indicate a systemic failure to adhere to regulatory requirements for medical device manufacturing.