Krispy Kreme Doughnut Corporation
Form 483 issued July 17, 2024
- Inspection
- Jul 9 – Jul 17, 2024
- Investigators
- Carol S. Davis· Narahi J. Alvarez Alcazar
- Observations
- 6
- Pages
- 4
- FEI number
- 1081922
In short: On July 17, 2024, FDA issued a Form 483 with 6 observations to Krispy Kreme Doughnut Corporation (FEI 1081922) after an inspection that ran Jul 9 – Jul 17, 2024. The investigators were Carol S. Davis and Narahi J. Alvarez Alcazar. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 117.135 (preventive controls).
At a glance
6 of 6 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 117.135 (2×) · 21 CFR 117.145 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your hazard analysis did not identify a hazard that…
- 0221 CFR 117.13521 CFR 117.145
You did not implement your sanitation preventive control…
- 0321 CFR 117.13521 CFR 117.145
You did not implement your process preventive…
- 04
You did not exclude pests from your food plant to protect…
This inspection in context
Questions about this 483
What did FDA find at Krispy Kreme Doughnut Corporation?
FDA listed 6 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 117.135 (preventive controls). The opening words of each observation are shown on this page.
Who inspected Krispy Kreme Doughnut Corporation?
Carol S. Davis and Narahi J. Alvarez Alcazar are named on this Form 483, for the inspection of Jul 9 – Jul 17, 2024. Each investigator has a profile showing what they cite most.
When was Krispy Kreme Doughnut Corporation inspected by FDA?
The inspection ran Jul 9 – Jul 17, 2024, and the Form 483 is dated July 17, 2024.
How do I get the full Form 483 for Krispy Kreme Doughnut Corporation?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.