FDA 483 - Blue Bell Creameries, LP - March 28, 2012

On March 28, 2012, an FDA inspection of Blue Bell Creameries, LP, an ice cream manufacturer located at 8201 E Highway 51, Broken Arrow, OK 74014-2900, revealed two observations.

Observation 1 cited a failure to manufacture foods under conditions and controls necessary to minimize contamination. An employee on the - line was observed handling "Nutty Chocolate Pre-Mix" for "Nutty Chocolate Ice Cream." The employee, after emptying shipping boxes and plastic liner bags of pre-mix into a fruit feeder, used a gloved hand to sweep remaining contents into the feeder. This employee was subsequently observed scratching their head, touching their cap and waistband, and then resuming contact with the pre-mix. The pre-mix from the feeder goes directly into the filling machine, mixing with ice cream for 1/2-gallon containers.

Observation 2 noted a failure to handle and maintain equipment, containers, and utensils used to hold food in a manner that protects against contamination. Inside the -degree cooler, two partial pallets of unlabeled bulk "inclusions" and/or ingredients were found with residue on the lids and sides of five-gallon buckets. Specifically, brown, dried residue was on at least three unmarked buckets, and yellowish, dried residue was on one marked bucket. A third partial pallet of "Maraschino Cherries" buckets also had reddish residue on at least two lids