Form 483

SunButter, LLC. Form 483, 2010-05-27

FDA issued a Form 483 to SunButter, LLC. on 2010-05-27 with 8 public-safe observations.

483· Form 483 issued8 observations

SunButter, LLC. · Fargo, United States · Issued May 27, 2010

Overview

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

27 May 2010
21 CFR 110.20(a)(2)

Roads/yards/parking lots

Cited by Darren D Holaday, Grant M Ruis, Gregory S Larson

27 May 2010
21 CFR 110.20(a)(3)

Drainage

Cited by Darren D Holaday, Grant M Ruis, Gregory S Larson

27 May 2010
21 CFR 110.20(b)(6)

Fans/air blowing equipment

Cited by Darren D Holaday, Grant M Ruis, Gregory S Larson

27 May 2010
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Darren D Holaday, Grant M Ruis, Gregory S Larson

27 May 2010
21 CFR 110.35(d)(3)

Non-food-contact surfaces (S)

Cited by Darren D Holaday, Grant M Ruis, Gregory S Larson

Inspected site

SLSunButter, LLC.Fargo, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(a)(2)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)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.40(b)Cited across public-safe Form 483 observations1x
21 CFR 110.40(c)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 8 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