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Form 483

Evig LLC dba Balance of Nature Form 483, 2019-02-08

FDA issued a Form 483 to Evig LLC dba Balance of Nature on 2019-02-08 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Evig LLC dba Balance of Nature · Saint George, United States · Issued February 8, 2019

Overview

  • 5 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.

8 Feb 2019
21 CFR 111.103

Written procedures - quality control operations

Cited by Matthew A Johnson

8 Feb 2019
21 CFR 111.503

Written procedures - returned dietary supplement

Cited by Matthew A Johnson

8 Feb 2019
21 CFR 111.553

Written procedures - product complaint

Cited by Matthew A Johnson

8 Feb 2019
21 CFR 111.503

Written procedures - returned dietary supplement

Cited by Matthew A Johnson

8 Feb 2019
21 CFR 111.553

Written procedures - product complaint

Cited by Matthew A Johnson

Inspected site

ELEvig LLC dba Balance of NatureSaint George, United States

Inspection team

MAMatthew A Johnson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.503Cited across public-safe Form 483 observations2x
21 CFR 111.553Cited across public-safe Form 483 observations2x
21 CFR 111.103Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 5 observations

The source PDF, 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