FDA Inspection 573129 — Clearwater Colon Hydrotherapy, Inc.
The FDA completed an inspection of Clearwater Colon Hydrotherapy, Inc. on April 2, 2009 in Ocala, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 2, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ocala, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 4189 | 21 CFR 820.198(a) | General |