FDA Inspection 777221 — Clearwater Colon Hydrotherapy, Inc.

Clearwater Colon Hydrotherapy, Inc. — FEI 3000718678

The FDA completed an inspection of Clearwater Colon Hydrotherapy, Inc. on April 13, 2012 in Ocala, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 13, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Ocala, FL (United States)

Citations

IDCFRDescription
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
315921 CFR 820.184DHR content
317121 CFR 820.198(b)Rationale documented for no investigation