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Form 483

Shelburne Farms Form 483, 2014-07-03

FDA issued a Form 483 to Shelburne Farms on 2014-07-03 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Shelburne Farms · Shelburne, United States · Issued July 3, 2014

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

3 Jul 2014
21 CFR 110.37(b)(3)

As source of contamination

Cited by Joseph T Frost

3 Jul 2014
21 CFR 110.80

Reasonable precautions

Cited by Joseph T Frost

3 Jul 2014
21 CFR 110.80(b)(8)

Metal / extraneous materials

Cited by Joseph T Frost

Inspected site

SFShelburne FarmsShelburne, United States

Inspection team

JTJoseph T Frost

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(8)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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