Blue Bell Creameries LP
Form 483 issued April 23, 2015 · Broken Arrow, Oklahoma
- Inspection
- Mar 23 – Apr 23, 2015
- Investigators
- Adam C. Hipko· Franklin R. Harris· Jennifer Owens Dowdy
- Observations
- 12
- Pages
- 11
- FEI number
- 1000118167
In short: On April 23, 2015, FDA issued a Form 483 with 12 observations to Blue Bell Creameries LP in Broken Arrow, Oklahoma (FEI 1000118167) after an inspection that ran Mar 23 – Apr 23, 2015. The investigators were Adam C. Hipko, Franklin R. Harris, Jennifer Owens Dowdy, Lloyd D. Payne and Travis D. Brown. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.80 (processes and controls).
At a glance
12 of 12 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
Failure to manufacture and package foods under conditions and controls necessary to minimize the potential for…
- 02
Failure to perform microbial testing where necessary to identify sanitation failures…
- 03
The procedure used for cleaning and sanitizing ofequipment and utensils has not been shown to provide…
- 04
Failure to provide running water at a suitable temperature for cleaning of equipment…
This inspection in context
Adam C. Hipko
1 document · 2015
Cites 110.80 (processes and controls) more than any other section. Most of their documents are for sites in Oklahoma.
The firmBlue Bell Creameries LP history
All 9 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 Blue Bell Creameries LP?
FDA listed 12 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 Blue Bell Creameries LP?
Adam C. Hipko, Franklin R. Harris, Jennifer Owens Dowdy, Lloyd D. Payne and Travis D. Brown are named on this Form 483, for the inspection of Mar 23 – Apr 23, 2015. Each investigator has a profile showing what they cite most.
When was Blue Bell Creameries LP inspected by FDA?
The inspection ran Mar 23 – Apr 23, 2015, and the Form 483 is dated April 23, 2015.
How do I get the full Form 483 for Blue Bell Creameries LP?
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.