Krispy Kreme Doughnut Corporation

Form 483 issued October 23, 2019 · Columbus, Ohio

Inspection
Oct 22 – Oct 23, 2019
Observations
4
Pages
5
FEI number
3004794454

In short: On October 23, 2019, FDA issued a Form 483 with 4 observations to Krispy Kreme Doughnut Corporation in Columbus, Ohio (FEI 3004794454) after an inspection that ran Oct 22 – Oct 23, 2019. Most observations concern food CGMP / preventive controls.

At a glance

4 of 4 observations on this 483 concern food cgmp / preventive controls.

Food CGMP / preventive controls4

What FDA observed

Preview: the opening words of each observation
  1. 01

    You did not take a reasonable measure and precaution…

  2. 02

    Your plant was not constructed and designed to facilitate…

  3. 03

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

  4. 04

    Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained…

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 4 observations on this Form 483, mostly about food CGMP / preventive controls. The opening words of each observation are shown on this page.

When was Krispy Kreme Doughnut Corporation inspected by FDA?

The inspection ran Oct 22 – Oct 23, 2019, and the Form 483 is dated October 23, 2019.

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

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