Form 483

AHN International Inc DBA Amazing Herbs Nutraceuticals Form 483, 2022-12-09

FDA issued a Form 483 to AHN International Inc DBA Amazing Herbs Nutraceuticals on 2022-12-09 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

AHN International Inc DBA Amazing Herbs Nutraceuticals · Buford, United States · Issued December 9, 2022

Overview

  • 6 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.

9 Dec 2022
21 CFR 111.205(b)(2)

Master manufacturing record - controls, procedures

Cited by Joseph F Owens

9 Dec 2022
21 CFR 111.205(b)(2)

Master manufacturing record - controls, procedures

Cited by Joseph F Owens

9 Dec 2022
21 CFR 111.255(b)

Batch record - complete

Cited by Joseph F Owens

9 Dec 2022
21 CFR 111.255(b)

Batch record - complete

Cited by Joseph F Owens

9 Dec 2022
21 CFR 111.355

Manufacturing operations - design

Cited by Joseph F Owens

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 111.255(b)Cited across public-safe Form 483 observations2x
21 CFR 111.355Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 observations

The full inspection record, as Atlas holds it, 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