Blue Bell Creameries LP
Form 483 issued March 28, 2012 · Broken Arrow, Oklahoma
- Inspection
- Mar 28, 2012
- Investigator
- Jennifer Owens
- Observations
- 2
- Pages
- 2
- FEI number
- 1000118167
In short: On March 28, 2012, FDA issued a Form 483 with 2 observations to Blue Bell Creameries LP in Broken Arrow, Oklahoma (FEI 1000118167) after an inspection that ran Mar 28, 2012. The investigator was Jennifer Owens. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.80 (processes and controls).
At a glance
2 of 2 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 110.80(b)(2) (1×) · 110.80(b)(7) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to manufacture foods under conditions and controls…
- 02
Failure to handle and maintain equipment, containers and utensils used to hold food in a manner…
This inspection in context
Jennifer Owens
1 document · 2012
Cites 110.80(b)(2) (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(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Blue Bell Creameries LP?
FDA listed 2 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?
Jennifer Owens is named on this Form 483, for the inspection of Mar 28, 2012. Each investigator has a profile showing what they cite most.
When was Blue Bell Creameries LP inspected by FDA?
The inspection ran Mar 28, 2012, and the Form 483 is dated March 28, 2012.
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.