Atlas

Form 483

Four Elements Organic Herbals, LLC Form 483, 2018-08-09

FDA issued a Form 483 to Four Elements Organic Herbals, LLC on 2018-08-09 with 84 public-safe observations.

483· Form 483 issuedFoods & Cosmetics84 observations

Four Elements Organic Herbals, LLC · North Freedom, United States · Issued August 9, 2018

Overview

  • 84 public-safe observations are available for this inspection.
  • 28 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.

9 Aug 2018
21 CFR 11

Electronic records

Cited by Melanie C Voges

9 Aug 2018
21 CFR 11

Electronic records

Cited by Melanie C Voges

9 Aug 2018
21 CFR 11

Electronic records

Cited by Melanie C Voges

9 Aug 2018
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Melanie C Voges

9 Aug 2018
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Melanie C Voges

Inspected site

FEFour Elements Organic Herbals, LLCNorth Freedom, United States

Inspection team

MCMelanie C Voges

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 11Cited across public-safe Form 483 observations3x
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations3x
21 CFR 110.10(c)Cited across public-safe Form 483 observations3x
21 CFR 110.35(a)Cited across public-safe Form 483 observations3x
21 CFR 110.37(a)Cited across public-safe Form 483 observations3x
21 CFR 110.37(d)(4)Cited across public-safe Form 483 observations3x
21 CFR 110.37(e)(4)Cited across public-safe Form 483 observations3x
21 CFR 110.80Cited across public-safe Form 483 observations3x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 111.155(c)Cited across public-safe Form 483 observations3x
21 CFR 111.160(c)Cited across public-safe Form 483 observations3x
21 CFR 111.205(a)Cited across public-safe Form 483 observations3x
21 CFR 111.255(b)Cited across public-safe Form 483 observations3x
21 CFR 111.303Cited across public-safe Form 483 observations3x
21 CFR 111.35(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 111.353Cited across public-safe Form 483 observations3x
21 CFR 111.403Cited across public-safe Form 483 observations3x
21 CFR 111.453Cited across public-safe Form 483 observations3x
21 CFR 111.535(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 111.553Cited across public-safe Form 483 observations3x
21 CFR 111.65Cited across public-safe Form 483 observations3x
21 CFR 111.70(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 111.70(b)(2)Cited across public-safe Form 483 observations3x
21 CFR 111.70(b)(3)Cited across public-safe Form 483 observations3x
21 CFR 111.70(e)Cited across public-safe Form 483 observations3x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations3x
21 CFR 111.83(a)Cited across public-safe Form 483 observations3x
FDCA 601(c)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 84 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