Form 483

Hard-E Foods Inc Form 483, 2010-05-07

FDA issued a Form 483 to Hard-E Foods Inc on 2010-05-07 with 4 public-safe observations.

483· Form 483 issued4 observations

Hard-E Foods Inc · Saint Louis, United States · Issued May 7, 2010

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

7 May 2010
21 CFR 110.80(b)(3)

Holding foods - refrigerate/freeze/heat

Cited by Sheri L Stephenson, April K Hill

7 May 2010
21 CFR 114.80(a)(2)

pH testing

Cited by Sheri L Stephenson, April K Hill

7 May 2010
21 CFR 114.83

Scheduled process establishment

Cited by Sheri L Stephenson, April K Hill

7 May 2010
21 CFR 114.100(b)

Processing and production - required information

Cited by Sheri L Stephenson, April K Hill

Inspected site

HFHard-E Foods IncSaint Louis, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 114.100(b)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 114.83Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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