FDA Inspection
Clearwater Colon Hydrotherapy, Inc.Clearwater Colon Hydrotherapy, Inc. – FDA Inspection, Feb 5, 2018
Record Details
This FDA Inspection record concerns Clearwater Colon Hydrotherapy, Inc., with an inspection on February 5, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3892a770-9d67-49a4-81d4-8460b1db1968
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039989
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Clearwater Colon Hydrotherapy, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2026 | NAI | Florida District Office | Postmarket Assurance: Medical Devices |
| July 2, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 13, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 2, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Clearwater Colon Hydrotherapy, Inc.
- FDA Inspection 1309530 - 2026-03-26
- FDA Inspection 933252 - 2015-07-02
- FDA Inspection 777221 - 2012-04-13
- FDA Inspection 573129 - 2009-04-02
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