Krispy Kreme Doughnut Corporation
Form 483 issued May 9, 2024 · Columbus, Ohio
- Inspection
- May 8 – May 9, 2024
- Investigator
- Carlos H. Ruiz Nunez
- Observations
- 2
- Pages
- 3
- FEI number
- 3004794454
In short: On May 9, 2024, FDA issued a Form 483 with 2 observations to Krispy Kreme Doughnut Corporation in Columbus, Ohio (FEI 3004794454) after an inspection that ran May 8 – May 9, 2024. The investigator was Carlos H. Ruiz Nunez. 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.
Most cited: 21 CFR 117.35 (1×) · 117.37 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You did not conduct operations under conditions and controls necessary to minimize the potential…
- 02
Your plant did not have adequate…
This inspection in context
Carlos H. Ruiz Nunez
1 document · 2024
Cites 117.35 (sanitary operations) more than any other section. Most of their documents are for sites in Ohio.
The firmKrispy Kreme Doughnut Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 117.35
See how FDA wrote the same problem up elsewhere.
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?
Carlos H. Ruiz Nunez is named on this Form 483, for the inspection of May 8 – May 9, 2024. Each investigator has a profile showing what they cite most.
When was Krispy Kreme Doughnut Corporation inspected by FDA?
The inspection ran May 8 – May 9, 2024, and the Form 483 is dated May 9, 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.