Form 483

Dixie Health Inc Form 483, 2017-01-26

FDA issued a Form 483 to Dixie Health Inc on 2017-01-26 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Dixie Health Inc · Marietta, United States · Issued January 26, 2017

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

26 Jan 2017
21 CFR 111.135

Quality control operations - product complaints; investigate

Cited by Sandra I Gaul

26 Jan 2017
21 CFR 111.503

Written procedures - returned dietary supplement

Cited by Sandra I Gaul

Inspected site

DHDixie Health IncMarietta, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.135Cited across public-safe Form 483 observations1x
21 CFR 111.503Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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