Form 483

Krispy Kreme Doughnut Corporation Form 483, 2016-12-02

FDA issued a Form 483 to Krispy Kreme Doughnut Corporation on 2016-12-02 with 12 public-safe observations.

483· Form 483 issuedFoods & Cosmetics12 observations

Krispy Kreme Doughnut Corporation · Tampa, United States · Issued December 2, 2016

Overview

  • 12 public-safe observations are available for this inspection.
  • 4 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.

2 Dec 2016
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Christos G Tsingelis, Christie A Soto, Leslie A Jackanicz

2 Dec 2016
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Christos G Tsingelis, Christie A Soto, Leslie A Jackanicz

2 Dec 2016
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Christos G Tsingelis, Christie A Soto, Leslie A Jackanicz

2 Dec 2016
21 CFR 110.20(b)(7)

Screening

Cited by Christos G Tsingelis, Christie A Soto, Leslie A Jackanicz

2 Dec 2016
21 CFR 110.20(b)(7)

Screening

Cited by Christos G Tsingelis, Christie A Soto, Leslie A Jackanicz

Inspected site

KKKrispy Kreme Doughnut CorporationTampa, 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 observations3x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations3x
21 CFR 110.35(a)Cited across public-safe Form 483 observations3x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 12 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