Form 483

Old Fashioned Foods, Inc. Form 483, 2012-05-04

FDA issued a Form 483 to Old Fashioned Foods, Inc. on 2012-05-04 with 12 public-safe observations.

483· Form 483 issued12 observations

Old Fashioned Foods, Inc. · Mayville, United States · Issued May 4, 2012

Overview

  • 12 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.

4 May 2012
21 CFR 108.25(c)(2)

Process filing

Cited by Nicole C Shokatz

4 May 2012
21 CFR 108.35(c)(2)

Process filing

Cited by Nicole C Shokatz

4 May 2012
21 CFR 108.35(c)(2)(ii)

Process change - increase

Cited by Nicole C Shokatz

4 May 2012
21 CFR 113.40(j)

Critical factors - frequency measured, recorded

Cited by Nicole C Shokatz

4 May 2012
21 CFR 113.83

Scheduled processes not established

Cited by Nicole C Shokatz

Inspected site

OFOld Fashioned Foods, Inc.Mayville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 113.89Cited across public-safe Form 483 observations2x
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 108.35(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 108.35(c)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 113.100(b)Cited across public-safe Form 483 observations1x
21 CFR 113.40(j)Cited across public-safe Form 483 observations1x
21 CFR 113.83Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 114.80(b)Cited across public-safe Form 483 observations1x
21 CFR 114.83Cited across public-safe Form 483 observations1x
21 CFR 114.89Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 12 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