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

Source: https://www.keypedia.com/records/483/clearwater-colon-hydrotherapy-inc/de94cfac-f115-4e95-9750-a36b0b4462d6

> FDA 483 for Clearwater Colon Hydrotherapy, Inc. on March 26, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clearwater Colon Hydrotherapy, Inc.
- Inspection Date: 2026-03-26
- Product Type: device
- Office Name: Florida District Office
- Summary: 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.

## Related Officers

- [Ulysses D. Singleton](https://www.keypedia.com/people/ulysses-d-singleton/e62f9da3-2c82-4ad7-910d-2da18144c789)

Company: https://www.keypedia.com/companies/clearwater-colon-hydrotherapy-inc/e7a145e1-93ad-450f-9508-5e8ae41d6324

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9