Form 483

Heartland Gourmet LLC Form 483, 2013-03-18

FDA issued a Form 483 to Heartland Gourmet LLC on 2013-03-18 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Heartland Gourmet LLC · Lincoln, United States · Issued March 18, 2013

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.

18 Mar 2013
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Zachary A Bogorad, Jonathan R Campos

18 Mar 2013
21 CFR 110.10(c)

Training of handlers and supervisors

Cited by Zachary A Bogorad, Jonathan R Campos

18 Mar 2013
21 CFR 110.35(d)

Failure to clean - general

Cited by Zachary A Bogorad, Jonathan R Campos

18 Mar 2013
21 CFR 110.40(a)

Precluding contaminants

Cited by Zachary A Bogorad, Jonathan R Campos

18 Mar 2013
21 CFR 110.80(a)(1)

Storage

Cited by Zachary A Bogorad, Jonathan R Campos

Inspected site

HGHeartland Gourmet LLCLincoln, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.10(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.93Cited 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