FDA Inspection 1309530 — Clearwater Colon Hydrotherapy, Inc.
The FDA completed an inspection of Clearwater Colon Hydrotherapy, Inc. on March 26, 2026 in Ocala, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 26, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ocala, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23038 | ISO 13485:2016 Clause 4.2.4 | Lack of document control |
| 23092 | ISO 13485:2016 Clause 7.2.2 | Review of requirements related to product not conducted |
| 23137 | ISO 13485:2016 Clause 7.3.10 | Design and development file does not include or reference required records |
| 23141 | ISO 13485:2016 Clause 7.4.1 | Supplier monitoring and re-evaluation not planned |
| 23174 | ISO 13485:2016 Clause 7.5.6 | Records of validation of processes and necessary actions not maintained |