Atlas

Form 483

Clearwater Colon Hydrotherapy, Inc. Form 483, 2009-04-02

FDA issued a Form 483 to Clearwater Colon Hydrotherapy, Inc. on 2009-04-02 with 3 public-safe observations.

483· Form 483 issued3 observations

Clearwater Colon Hydrotherapy, Inc. · Ocala, United States · Issued April 2, 2009

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

2 Apr 2009
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Salvatore N Randazzo

2 Apr 2009
21 CFR 820.198(a)

General

Cited by Salvatore N Randazzo

2 Apr 2009
21 CFR 820.198(e)(6)

Results of investigation

Cited by Salvatore N Randazzo

Inspected site

CCClearwater Colon Hydrotherapy, Inc.Ocala, United States

Inspection team

SNSalvatore N Randazzo

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(e)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere