Form 483

AHN International Inc DBA Amazing Herbs Nutraceuticals Form 483, 2019-06-20

FDA issued a Form 483 to AHN International Inc DBA Amazing Herbs Nutraceuticals on 2019-06-20 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

AHN International Inc DBA Amazing Herbs Nutraceuticals · Buford, United States · Issued June 20, 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.

20 Jun 2019
21 CFR 111.205(b)(2)

Master manufacturing record - controls, procedures

Cited by Sondra L Phillips

20 Jun 2019
21 CFR 111.255(b)

Batch record - complete

Cited by Sondra L Phillips

20 Jun 2019
21 CFR 111.503

Written procedures - returned dietary supplement

Cited by Sondra L Phillips

20 Jun 2019
21 CFR 111.205(b)(2)

Master manufacturing record - controls, procedures

Cited by Sondra L Phillips

20 Jun 2019
21 CFR 111.503

Written procedures - returned dietary supplement

Cited by Sondra L Phillips

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.205(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 111.503Cited across public-safe Form 483 observations2x
21 CFR 111.255(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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