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Form 483

Shelburne Farms Form 483, 2012-08-23

FDA issued a Form 483 to Shelburne Farms on 2012-08-23 with 2 public-safe observations.

483· Form 483 issued2 observations

Shelburne Farms · Shelburne, United States · Issued August 23, 2012

Overview

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

Inspectional observations

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

23 Aug 2012
21 CFR 110.37(b)(3)

As source of contamination

Cited by Abby E Pelletier, Douglas S Joslin, Matthew D Silverman

23 Aug 2012
21 CFR 110.80

Reasonable precautions

Cited by Abby E Pelletier, Douglas S Joslin, Matthew D Silverman

Inspected site

SFShelburne FarmsShelburne, United States

Inspection team

AEAbby E Pelletier
DSDouglas S Joslin
MDMatthew D Silverman

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

Full 483 report

Get the verbatim text of all 2 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