Form 483

Natural Awe LLC., dba Hobe Labs Form 483, 2018-06-12

FDA issued a Form 483 to Natural Awe LLC., dba Hobe Labs on 2018-06-12 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Natural Awe LLC., dba Hobe Labs · Tempe, United States · Issued June 12, 2018

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.

12 Jun 2018
21 CFR 111.12(b)

Personnel - quality control operations

Cited by Devon Jenkins

12 Jun 2018
21 CFR 111.75(a)(1)(i)

Component - verify identity, dietary ingredient

Cited by Devon Jenkins

12 Jun 2018
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

Cited by Devon Jenkins

Inspected site

NANatural Awe LLC., dba Hobe LabsTempe, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.12(b)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(A)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