Dixie De1-1 Products Inc.
Form 483 issued March 15, 2017 · Erlanger, Kentucky
- Inspection
- Mar 3 – Mar 15, 2017
- Investigators
- Andrew M. Kupper· Kenneth E. Felkley· Mary B. Sheets
- Observations
- 10
- Pages
- 8
- FEI number
- 1022121
In short: On March 15, 2017, FDA issued a Form 483 with 10 observations to Dixie De1-1 Products Inc. in Erlanger, Kentucky (FEI 1022121) after an inspection that ran Mar 3 – Mar 15, 2017. The investigators were Andrew M. Kupper, Kenneth E. Felkley and Mary B. Sheets. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 117.80 (processes and controls).
At a glance
10 of 10 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 117.80 (3×) · 117.20 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to manufacture and package foods under conditions and controls necessary to minimize the potential fo…
- 02
All reasonable precautions are not taken to ensure that production procedures do not contribute…
- 03
Hand-washing facil ities lack running water…
- 04
Failure to maintain equipment in an acceptable condition through…
This inspection in context
Andrew M. Kupper
2 documents · 2016–2017
Cites 117.20 (plant and grounds) more than any other section. Most of their documents are for sites in Kentucky.
The firmDixie De1-1 Products Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 117.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dixie De1-1 Products Inc.?
FDA listed 10 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 117.80 (processes and controls). The opening words of each observation are shown on this page.
Who inspected Dixie De1-1 Products Inc.?
Andrew M. Kupper, Kenneth E. Felkley and Mary B. Sheets are named on this Form 483, for the inspection of Mar 3 – Mar 15, 2017. Each investigator has a profile showing what they cite most.
When was Dixie De1-1 Products Inc. inspected by FDA?
The inspection ran Mar 3 – Mar 15, 2017, and the Form 483 is dated March 15, 2017.
How do I get the full Form 483 for Dixie De1-1 Products Inc.?
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.