Form 483

AHN International Inc DBA Amazing Herbs Nutraceuticals Form 483, 2012-05-30

FDA issued a Form 483 to AHN International Inc DBA Amazing Herbs Nutraceuticals on 2012-05-30 with 8 public-safe observations.

483· Form 483 issued8 observations

AHN International Inc DBA Amazing Herbs Nutraceuticals · Buford, United States · Issued May 30, 2012

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 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.

30 May 2012
21 CFR 111.14(b)(1)

Personnel - records - written procedures

Cited by Seneca D Toms

30 May 2012
21 CFR 111.75(a)(1)(i)

Component - verify identity, dietary ingredient

Cited by Seneca D Toms

30 May 2012
21 CFR 111.105(a)

Processes, specifications, written procedures

Cited by Seneca D Toms

30 May 2012
21 CFR 111.123(a)(8)

Quality control - finished batch, distribution

Cited by Seneca D Toms

30 May 2012
21 CFR 111.135

Quality control operations - product complaints; investigate

Cited by Seneca D Toms

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.105(a)Cited across public-safe Form 483 observations1x
21 CFR 111.123(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 111.135Cited across public-safe Form 483 observations1x
21 CFR 111.14(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.205(a)Cited across public-safe Form 483 observations1x
21 CFR 111.255(a)Cited across public-safe Form 483 observations1x
21 CFR 111.515Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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