Form 483

Gedney Foods Company Form 483, 2011-07-15

FDA issued a Form 483 to Gedney Foods Company on 2011-07-15 with 9 public-safe observations.

483· Form 483 issued9 observations

Gedney Foods Company · Chaska, United States · Issued July 15, 2011

Overview

  • 9 public-safe observations are available for this inspection.
  • 8 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.

15 Jul 2011
21 CFR 108.25(c)(3)(i)

Process adherence

Cited by Elizabeth P Mayer, Mada A Tautges

15 Jul 2011
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Elizabeth P Mayer, Mada A Tautges

15 Jul 2011
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Elizabeth P Mayer, Mada A Tautges

15 Jul 2011
21 CFR 110.20(a)(1)

Harborage areas

Cited by Elizabeth P Mayer, Mada A Tautges

15 Jul 2011
21 CFR 110.20(b)(7)

Screening

Cited by Elizabeth P Mayer, Mada A Tautges

Inspected site

GFGedney Foods CompanyChaska, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations2x
21 CFR 108.25(c)(3)(i)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(7)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 9 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