Krispy Kreme Doughnut Corporation

Form 483 issued July 15, 2022 · Columbus, Ohio

Inspection
Jul 14 – Jul 15, 2022
Observations
2
Pages
4
FEI number
3004794454

In short: On July 15, 2022, FDA issued a Form 483 with 2 observations to Krispy Kreme Doughnut Corporation in Columbus, Ohio (FEI 3004794454) after an inspection that ran Jul 14 – Jul 15, 2022. The investigator was Catherine D. Djordjevic. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 117.35 (sanitary operations).

At a glance

2 of 2 observations on this 483 concern food cgmp / preventive controls.

Food CGMP / preventive controls2

Most cited: 21 CFR 117.35(a) (1×) · 117.80(c) (1×)

What FDA observed

Preview: the opening words of each observation
  1. 01

    You did not maintain your plant in a clean and sanitary condition…

  2. 02

    You did not conduct operations under conditions and controls necessary to minimize the potential…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

Questions about this 483

What did FDA find at Krispy Kreme Doughnut Corporation?

FDA listed 2 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 117.35 (sanitary operations). The opening words of each observation are shown on this page.

Who inspected Krispy Kreme Doughnut Corporation?

Catherine D. Djordjevic is named on this Form 483, for the inspection of Jul 14 – Jul 15, 2022. Each investigator has a profile showing what they cite most.

When was Krispy Kreme Doughnut Corporation inspected by FDA?

The inspection ran Jul 14 – Jul 15, 2022, and the Form 483 is dated July 15, 2022.

How do I get the full Form 483 for Krispy Kreme Doughnut Corporation?

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