FDA Inspection
Clearwater Colon Hydrotherapy, Inc.Clearwater Colon Hydrotherapy, Inc. – FDA Inspection, Mar 26, 2026
Record Details
This FDA Inspection record concerns Clearwater Colon Hydrotherapy, Inc., with an inspection on March 26, 2026, issued by the Florida District Office, covering medical devices & rad health.
- Inspection Date
- March 26, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 4a834766-6824-44da-8cb2-341f081ef3a1
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1309530
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
10- ISO 13485:2016 Clause 7.4.3Review of requirements related to product not conducted
- ISO 13485:2016 Clause 4.2.4Lack of document control
- ISO 13485:2016 Clause 7.4.1Supplier monitoring and re-evaluation not planned
- ISO 13485:2016 Clause 4.1.3QMS not documented and maintained adequately
- ISO 13485:2016 Clause 7.5.8Records of validation of processes and necessary actions not maintained
- ISO 13485:2016 Clause 7.3.9Design and development file does not include or reference required records
- ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
- ISO 13485:2016 Clause 7.3.10Design and development file does not include or reference required records
- ISO 13485:2016 Clause 7.5.6Records of validation of processes and necessary actions not maintained
- ISO 13485:2016 Clause 7.2.2Review of requirements related to product not conducted
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Clearwater Colon Hydrotherapy, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2018 | VAI | Center for Devices and Radiological Health | Compliance: 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 1039989 - 2018-02-05
- FDA Inspection 933252 - 2015-07-02
- FDA Inspection 777221 - 2012-04-13
- FDA Inspection 573129 - 2009-04-02
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