Form 483

Fresh Frozen Foods Form 483, 2015-05-14

FDA issued a Form 483 to Fresh Frozen Foods on 2015-05-14 with 13 public-safe observations.

483· Form 483 issuedFoods & Cosmetics13 observations

Fresh Frozen Foods · Jefferson, United States · Issued May 14, 2015

Overview

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

Inspectional observations

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

14 May 2015
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Robin N Goins, Tyrico K English, Sherry R Dunn, David P Moorhead

14 May 2015
21 CFR 110.37(f)

Odor, attractant for pests, harborage

Cited by Robin N Goins, Tyrico K English, Sherry R Dunn, David P Moorhead

14 May 2015
21 CFR 110.80(b)(13)

Filling, assembling, packing controls

Cited by Robin N Goins, Tyrico K English, Sherry R Dunn, David P Moorhead

14 May 2015
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Robin N Goins, Tyrico K English, Sherry R Dunn, David P Moorhead

14 May 2015
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Robin N Goins, Tyrico K English, Sherry R Dunn, David P Moorhead

Inspected site

FFFresh Frozen FoodsJefferson, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations2x
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)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)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
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(13)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x

Source document

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PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 13 observations

The source PDF and 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