http://www.foodsafetynews.com/2015/05/fda-inspectors-report-long-list-of-problems-at-three-blue-bell-plants/#.VUzHvpMyhf0
CEO says products won't be back for several months
By Cathy Siegner | May 7, 2015
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.
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.
Observation 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.
Observation 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.
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