Form 483

AHN International Inc DBA Amazing Herbs Nutraceuticals Form 483, 2011-03-02

FDA issued a Form 483 to AHN International Inc DBA Amazing Herbs Nutraceuticals on 2011-03-02 with 11 public-safe observations.

483· Form 483 issued11 observations

AHN International Inc DBA Amazing Herbs Nutraceuticals · Buford, United States · Issued March 2, 2011

Overview

  • 11 public-safe observations are available for this inspection.
  • 11 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.

2 Mar 2011
21 CFR 111.12(b)

Personnel - quality control operations

Cited by Joseph F Owens

2 Mar 2011
21 CFR 111.14(b)(1)

Personnel - records - written procedures

Cited by Joseph F Owens

2 Mar 2011
21 CFR 111.15(f)(5)

Plumbing - backflow, cross connection

Cited by Joseph F Owens

2 Mar 2011
21 CFR 111.20(c)(3)

Physical plant - separate areas for products

Cited by Joseph F Owens

2 Mar 2011
21 CFR 111.20(f)

Physical plant - bulbs, fixtures, skylights

Cited by Joseph F Owens

Inspected site

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 111.14(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.15(f)(5)Cited across public-safe Form 483 observations1x
21 CFR 111.153Cited across public-safe Form 483 observations1x
21 CFR 111.155(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.20(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 111.20(f)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 111.27(d)Cited across public-safe Form 483 observations1x
21 CFR 111.375(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 11 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