Form 483

American Nutritional Corp., Inc Form 483, 2015-10-09

FDA issued a Form 483 to American Nutritional Corp., Inc on 2015-10-09 with 52 public-safe observations.

483· Form 483 issuedFoods & Cosmetics52 observations

American Nutritional Corp., Inc · Las Vegas, United States · Issued October 9, 2015

Overview

  • 52 public-safe observations are available for this inspection.
  • 13 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 Oct 2015
21 CFR 111.15(b)(2)

Physical plant - repair

Cited by Helen J Hamaoka

9 Oct 2015
21 CFR 111.15(b)(2)

Physical plant - repair

Cited by Helen J Hamaoka

9 Oct 2015
21 CFR 111.15(b)(2)

Physical plant - repair

Cited by Helen J Hamaoka

9 Oct 2015
21 CFR 111.15(b)(2)

Physical plant - repair

Cited by Helen J Hamaoka

9 Oct 2015
21 CFR 111.20(c)(7)

Physical plant - separate areas - holding

Cited by Helen J Hamaoka

Inspected site

ANAmerican Nutritional Corp., IncLas Vegas, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.15(b)(2)Cited across public-safe Form 483 observations4x
21 CFR 111.20(c)(7)Cited across public-safe Form 483 observations4x
21 CFR 111.205(b)(1)Cited across public-safe Form 483 observations4x
21 CFR 111.205(b)(2)Cited across public-safe Form 483 observations4x
21 CFR 111.255(b)Cited across public-safe Form 483 observations4x
21 CFR 111.260(g)Cited across public-safe Form 483 observations4x
21 CFR 111.315(b)Cited across public-safe Form 483 observations4x
21 CFR 111.365Cited across public-safe Form 483 observations4x
21 CFR 111.70(b)(2)Cited across public-safe Form 483 observations4x
21 CFR 111.70(d)Cited across public-safe Form 483 observations4x
21 CFR 111.70(e)Cited across public-safe Form 483 observations4x
21 CFR 111.75(c)(3)Cited across public-safe Form 483 observations4x
21 CFR 111.95(b)(3)Cited across public-safe Form 483 observations4x

Full 483 report

Get the verbatim text of all 52 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