Form 483

Krispy Kreme Doughnut Corporation Form 483, 2015-09-08

FDA issued a Form 483 to Krispy Kreme Doughnut Corporation on 2015-09-08 with 15 public-safe observations.

483· Form 483 issuedFoods & Cosmetics15 observations

Krispy Kreme Doughnut Corporation · Jacksonville, United States · Issued September 8, 2015

Overview

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

Inspectional observations

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

8 Sep 2015
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Donald J Mee, Henry L Lennon

8 Sep 2015
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Donald J Mee, Henry L Lennon

8 Sep 2015
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Donald J Mee, Henry L Lennon

8 Sep 2015
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Donald J Mee, Henry L Lennon

8 Sep 2015
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Donald J Mee, Henry L Lennon

Inspected site

KKKrispy Kreme Doughnut CorporationJacksonville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations3x
21 CFR 110.37(e)(1)Cited across public-safe Form 483 observations3x
21 CFR 110.80(b)(8)Cited across public-safe Form 483 observations3x
21 CFR 110.93Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 15 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