Form 483

Krispy Kreme Doughnut Corporation Form 483, 2010-05-07

FDA issued a Form 483 to Krispy Kreme Doughnut Corporation on 2010-05-07 with 13 public-safe observations.

483· Form 483 issued13 observations

Krispy Kreme Doughnut Corporation · Tampa, United States · Issued May 7, 2010

Overview

  • 13 public-safe observations are available for this inspection.
  • 10 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.

7 May 2010
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Laura B Kennedy, Samantha J Pinizzotto, Leo J Lagrotte

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

Adequate ventilation

Cited by Laura B Kennedy, Samantha J Pinizzotto, Leo J Lagrotte

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

Fans/air blowing equipment

Cited by Laura B Kennedy, Samantha J Pinizzotto, Leo J Lagrotte

7 May 2010
21 CFR 110.35(a)

Buildings/good repair

Cited by Laura B Kennedy, Samantha J Pinizzotto, Leo J Lagrotte

7 May 2010
21 CFR 110.35(a)

Buildings/sanitary

Cited by Laura B Kennedy, Samantha J Pinizzotto, Leo J Lagrotte

Inspected site

KKKrispy Kreme Doughnut CorporationTampa, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations3x
21 CFR 110.20(b)(6)Cited across public-safe Form 483 observations2x
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 13 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