Inspection teams from the U.S. Food and Drug Administration (FDA) reported numerous problems after recent visits to three production facilities owned and operated by Blue Bell Creameries of Brenham, TX. The company announced April 20 that it was recalling all products (ice cream, frozen yogurt, sherbet and frozen desserts) manufactured at all of its plants after receiving positive Listeria monocytogenes test results from samples of ice cream made at two different facilities. Blue Bell products have been linked to 10 confirmed listeriosis cases in four states and three deaths.

Blue Bell Creameries plant in Texas
The Blue Bell Creameries plant in Brenham, TX.
According to the company’s most recent update posted Thursday, its main production plant in Brenham, one in Broken Arrow, OK, and one in Sylacauga, AL, are now closed, and no ice cream is being produced at this time. Here are some observations from the FDA inspection reports for each Blue Bell facility: Brenham, TX: FDA inspectors visited this plant on 13 different occasions between March 16 and May 1, 2015, including every day of one week (March 16-20). The team made six separate observations in its report. Observation 1: Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms. FDA’s report noted that after specific lots of the company’s Great Divide Bar and Chocolate Chip Country Cookie were sampled and found positive for Listeria, routine cleaning and overhauling was done, and the Texas Department of State Health Services (DSHS) later informed the company that additional Listeria had been found in its products. Before resuming production, FDA stated that Blue Bell then swabbed its production line equipment and found the pathogen on the inside and outside drains of the freezer tunnel. Further, according to the report, following routine cleaning and sanitizing after numerous manufacturing days in March, Blue Bell found Listeria-positive swabs in the bottom and underside of the chainsprocket. Observation 2: The procedure used for cleaning and sanitizing of equipment has not been shown to provide adequate cleaning and sanitizing treatment. Blue-Bell_406x250Observation 3: The plant is not constructed in such a manner as to prevent condensate from contaminating food and food-contact surfaces. The FDA team observed condensate and drip throughout the facility, including “dripping directly into ice cream products.” Observation 4: Failure to clean food-contact surfaces as frequently as necessary to protect against contamination of food. FDA stated that all of the ingredient hoppers in the blending room were not kept clean and were “caked with emulsifiers and stabilizers which had mixed with humidity found in the room.” Observation 5: Failure to wear beard covers in an effective manner. Observation 6: Failure to maintain buildings in repair sufficient to prevent food from becoming contaminated. FDA specifically noted chipped and cracking paint on the ceiling and door guards with deep grooves that could not be easily cleaned. Broken Arrow, OK: Of the three Blue Bell plants inspected, this facility had the most observations listed (12). Inspectors visited the Oklahoma plant 11 different times between March 23-April 23, including daily during the week of March 23-27, 2015. Observation 1: Failure to manufacture and package foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination. Two Blue Bell products made at the Oklahoma plant tested positive for Listeria contamination, FDA noted. They were Institutional Chocolate Ice Cream in a 3-ounce cup with a pull-tab lid and a pint of Banana Pudding Ice Cream. The company indicated March 13 that it removed the products from distribution and shut down the affected production line. The FDA inspection report also stated that Blue Bell’s Banana Pudding Ice Cream, Lot code 021217S, produced on Feb. 12, 2015, tested positive by the agency for Listeria monocytogenes, and the company distributed pints of that flavor from that lot code to customers between Feb. 12 and March 26, 2015. Observation 2: Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination. FDA stated that the company’s sampling programs for environmental pathogens and daily total coliform sampling were inadequate. Observation 3: The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment. The plant continued to have presumptive positive environmental test results for Listeria and elevated total coliform results following daily cleaning and sanitizing of equipment and facilities, the FDA report stated. Further, coliform levels were higher than allowed by the Oklahoma Department of Agriculture, Food, and Forestry. That agency has a regulatory requirement of 20 CFUs/mL (colony forming units per milliliter) in finished products of frozen dairy desserts, FDA noted, yet samples of Homemade Vanilla Ice Cream from the OK plant yielded levels as high as 840 CFUs/mL. Observation 4: Failure to provide running water at a suitable temperature for cleaning equipment, utensils and food-packaging materials. Water temperatures for washing and rinsing equipment were not adequate monitored, verified or documented, FDA inspectors reported. Observation 5: The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food, food-contact surfaces, and food-packaging materials. Blue Bell banana pudding pintObservation 6: Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated. FDA inspectors stated that they observed several examples of Blue Bell employees touching non-food contact surfaces and food contact surfaces using the same pair of gloves. Observation 7: Failure to store cleaned and sanitized portable equipment in a location and manner which protects food-contact surfaces from contamination. Observation 8: All reasonable precaution are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, FDA stated that no required cleaning and sanitizing procedures were in place to keep employees’ shoes from contaminating the sanitary food production areas of the plant. Observation 9: The design of equipment does not allow proper cleaning and maintenance. Observation 10: Failure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated. FDA noted several “elevated temperature excursions” above 45 degrees F. involving unpasteurized milk products used as raw ingredients. Observation 11: Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles and organic matter and the opportunity for growth of microorganisms. Observation 12: Failure to take apart equipment as necessary to ensure thorough cleaning. FDA stated that the front faceplate of a freeze was not disassembled to throughly clean the gasket to make sure there was no leakage of the ready-to-eat ice cream and sherbet. When the faceplate was removed on March 22, “the gasket was observed to have black mold-like residual” on the flat portions forming a seal against the faceplate and freeze body, inspectors said. Sylacauga, AL: This facility was visited nine different times between April 6-30, 2015, by FDA inspectors, including every day during the week of April 6-10. There were eight separate observations listed in the agency’s inspection report. Observation 1: Failure to perform microbial testing where necessary to identify possible food contamination. FDA stated that the plant’s sampling program failed to include sampling of food contact surfaces, determination of any preventive action needed in response to possible contamination, determination of the impact on products produced on the affected date, and determination of the Listeria sub-species associated with the presumptive positive results. Observation 2: Suitable outer garments are not worn that protect against contamination of food and food contact surfaces. According to the inspection report, “An employee’s shirt came into direct contact with the interior liner of an ingredient container while the employee was loading the ingredients into Fruit Feeder” while making Bride’s Cake Ice Cream. “The employee, who was not dressed in the appropriate Blue Bell outer garment, was wearing a shirt which appeared soiled and with several holes,” the report noted. Observation 3: Failure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives. The inspection report stated that some equipment pieces were observed in an employee hand sink immediately following the line after production. Observation 4: The design and materials of equipment and utensils does not allow proper cleaning. FDA noted that a tool was used on the cone line adjacent to exposed product and a space heater was observed fastened to production equipment with duct tape directly under the chocolate tray … during production of Mooo Bars. Observation 5: All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. FDA inspectors noted that, on April 20, a “maintenance employee, with visibly soiled arms and shirt, was observed leaning on a package machine during production of Nutzo Ice Cream Cones. The employee’s arms were resting on the packaging equipment and extending over exposed product and open packaging.” Observation 6: Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated. Observation 7: The plaint is not constructed in such a manner as to prevent condensate from contaminating food-contact surfaces. Inspectors noted that the drop ceiling in the mixing room was damaged and in poor repair. Tiles appeared to be stained and broken throughout the mixing room, and a light fixture above a mixing tank had condensate on it. Observation 8: Non food-contact equipment in manufacturing areas is not constructed so that it can be kept in a clean condition. Blue Bell Creameries logoIn the Thursday update, Blue Bell CEO Paul Kruse said the company was in the process of preparing detailed responses to each of the FDA inspection reports. In addition, he detailed the cleaning and sanitizing process being undertaken at each of the company’s production facilities and said that all operating procedures would be reviewed and every step of the production process analyzed to eliminate possible contamination pathways. Kruse said facility repairs will be made, equipment will be taken apart and steam cleaned, and all HVAC systems will be inspected and sanitized, among other improvements. All of this work will take longer than previously anticipated, he acknowledged, with each facility having its own timetable for resuming production. He added that there is no definite schedule for returning the company’s products to the marketplace. “Unfortunately, we do not yet have a firm timeline for when Blue Bell Ice Cream will be back in stores, but we believe at this time that it will be several months at a minimum,” Kruse said. He also noted that the company has collected 8 million gallons of ice cream and related products from the marketplace and that “this phase of the product recall is now complete.”

  • Roy Costa

    These factors unfortunately can be found in many of our aging dairies, only one new dairy has been constructed in the last few years and many operations are 50 years old plus. The dairy industry is under some very strict price pressure, economics are important underlying factor that is not appreciated. Listeria contamination is a systemic problem that takes more than superficial treatment to address. Much more agressive actions are needed by the dairy industry. Two other drivers are increased testing and better diagnostics that are driving reported incidence.

  • Gary

    Honestly, this isn’t really a shock. When you face an issue of this magnitude in all of your facilities the food safety/quality culture is just not there. Upper management either did not supply adequate resources to enable a strong culture of food safety/quality (which is likely) or it wasn’t take seriously at any level in any of the facilities. It tells me senior management is wholly to blame.

  • Vicki

    WOW!!! How were none of these caught earlier??

  • L Studevant

    Human error or oversite to preventable problems is all too often STILL the problem. How long until environmental health is taken seriously?

  • Sherry April Bailey

    For Whom The Bell Tolls, Flee From Blue Bell Products!