FDA 483 - Blue Bell Creameries, LP - April 23, 2015

From March 23 to April 23, 2015, the FDA inspected Blue Bell Creameries, LP, a frozen dairy dessert manufacturer in Broken Arrow, OK. The inspection revealed 11 observations.

The primary finding was the failure to manufacture and package foods under conditions that minimize microbial growth and contamination. Specifically, ready-to-eat frozen dairy desserts tested positive for *Listeria monocytogenes*. This included Institutional Chocolate Ice Cream (Lot 041516Q), an unnamed product produced on March 23, 2015, and Banana Pudding Ice Cream (Lot 021217S). These findings led to a series of voluntary recalls, eventually encompassing all products manufactured by the firm.

Further observations included: - Failure to perform necessary microbial testing to identify sanitation failures and contamination, specifically lacking sampling of food contact surfaces, preventative action determination, impact assessment, *Listeria* species determination, and root cause analysis for environmental and coliform testing. - Ineffective cleaning and sanitizing procedures, evidenced by recurring presumptive positive environmental test results for *Listeria* spp. and elevated total coliform results. - Inadequate water temperature for cleaning equipment and utensils, with documented temperatures below recommended sanitizer instructions. - Plant construction issues, with condensation dripping from product supply lines onto flavor tanks and potentially contaminating post-pasteurized ice cream mixes. - Employee hygiene failures, including observed instances of not changing gloves