Jeni's Splendid Ice Creams, LLC
Form 483 issued April 30, 2015 · Columbus, Ohio
- Inspection
- Apr 20 – Apr 30, 2015
- Investigators
- Craig P. Seaborn· Darren S. Morgan· Matthew B. Casale
- Observations
- 11
- Pages
- 6
- FEI number
- 3008586462
In short: On April 30, 2015, FDA issued a Form 483 with 11 observations to Jeni's Splendid Ice Creams, LLC in Columbus, Ohio (FEI 3008586462) after an inspection that ran Apr 20 – Apr 30, 2015. The investigators were Craig P. Seaborn, Darren S. Morgan and Matthew B. Casale. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.80 (processes and controls).
At a glance
11 of 11 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 110.80 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Responsibility for assuring compliance with current good manufacturing practices relating to personnel bas not been assigned…
- 02
Failure to perform microbial testing where necessary to identify sanitation failures…
- 03
Failure to provide sufficient space for placement of equipment and storage ofmaterials as necessary for the…
- 04
Failure to maintain buildings, fixtures , or other physical facilities…
This inspection in context
Craig P. Seaborn
2 documents · 2015
Cites 110.80 (processes and controls) more than any other section. Most of their documents are for sites in Ohio.
The firmJeni's Splendid Ice Creams, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 110.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jeni's Splendid Ice Creams, LLC?
FDA listed 11 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 110.80 (processes and controls). The opening words of each observation are shown on this page.
Who inspected Jeni's Splendid Ice Creams, LLC?
Craig P. Seaborn, Darren S. Morgan and Matthew B. Casale are named on this Form 483, for the inspection of Apr 20 – Apr 30, 2015. Each investigator has a profile showing what they cite most.
When was Jeni's Splendid Ice Creams, LLC inspected by FDA?
The inspection ran Apr 20 – Apr 30, 2015, and the Form 483 is dated April 30, 2015.
How do I get the full Form 483 for Jeni's Splendid Ice Creams, LLC?
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.