Clearwater Colon Hydrotherapy, Inc.
3145 SW 74th Ter, OCALA, FL, US
Registered product codes
2 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3000718678.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 26, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Mar 26, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
1ISO 13485:2016 Clause 4.2.4Lack of document control
1ISO 13485:2016 Clause 7.2.2Review of requirements related to product not conducted
1ISO 13485:2016 Clause 7.3.10Design and development file does not include or reference required records
1ISO 13485:2016 Clause 7.4.1Supplier monitoring and re-evaluation not planned
1ISO 13485:2016 Clause 7.5.6Records of validation of processes and necessary actions not maintained
1
- ISO 13485:2016 Clause 4.1.1Mar 26, 2026
QMS not documented and maintained adequately
- ISO 13485:2016 Clause 4.2.4Mar 26, 2026
Lack of document control
- ISO 13485:2016 Clause 7.2.2Mar 26, 2026
Review of requirements related to product not conducted
- ISO 13485:2016 Clause 7.3.10Mar 26, 2026
Design and development file does not include or reference required records
- ISO 13485:2016 Clause 7.4.1Mar 26, 2026
Supplier monitoring and re-evaluation not planned
- ISO 13485:2016 Clause 7.5.6Mar 26, 2026
Records of validation of processes and necessary actions not maintained
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.