Form 483

Heartland Products Inc. Form 483, 2011-05-09

FDA issued a Form 483 to Heartland Products Inc. on 2011-05-09 with 6 public-safe observations.

483· Form 483 issued6 observations

Heartland Products Inc. · Des Moines, United States · Issued May 9, 2011

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

9 May 2011
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Collins M Mason, Brittany D Terhar

9 May 2011
21 CFR 110.35(a)

Buildings/sanitary

Cited by Collins M Mason, Brittany D Terhar

9 May 2011
21 CFR 110.35(d)

Failure to clean - general

Cited by Collins M Mason, Brittany D Terhar

9 May 2011
21 CFR 110.35(e)

Storage of cleaned portable equipment (S)

Cited by Collins M Mason, Brittany D Terhar

9 May 2011
21 CFR 110.37(f)

Odor, attractant for pests, harborage

Cited by Collins M Mason, Brittany D Terhar

Inspected site

HPHeartland Products Inc.Des Moines, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.35(e)Cited across public-safe Form 483 observations1x
21 CFR 110.37(f)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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