May 29, 2024

Attorney Discusses Blue Bell FDA Inspection Reports

Attorney Fred Pritzker, who is representing people sickened in the Blue Bell ice cream Listeria outbreak, discusses the FDA inspection reports about the company’s facility. Since ice cream is a ready-to-eat food with no consumer “kill step” of cooking, any finding of Listeria monocytogenes bacteria in the plant is a serious issue.

Listeria bacteria was present in the Broken Arrow, Oklahoma Blue Bell processing plant as early as March 2013, according to the report. Blue Bell was notified of its “improper cleaning” and continued to ship product from the facility.

The company knew they had a “pervasive Listeria infestation in their plant. In the Broken Arrow, Oklahoma plant, they sanitized using normal procedures, and subsequent tests found more Listeria. In other words, the cleaning processes were not sufficient. “The company had a problem, they knew they  had a problem, and they didn’t correct it,” Flaherty said.

At least 10 people have developed listeriosis in conjunction with this outbreak. Three deaths of patients in Kansas occurred this year as a result of listeriosis linked to Blue Bell products. Last month Blue Bell recalled all of its products and stopped manufacturing.

The FDA publishes Form 483, the document produced after an FDA inspection of a regulated processing facility. It is the “essence” of violations of the federal Food, Drug & Cosmetic Act during the inspection process, according to Flaherty.

The three strains related to the illnesses reported in Kansas, and four other rare strains of Listeria monocytogenes were found in samples of Blue Bell Creameries single serving Chocolate Chip County Cookie Sandwich and the Great Divide Bar ice cream products. The Texas Department of State Health Services collected product samples from the Blue Bell Creameries Brenham, Texas facility. Listeria monocytogenes was present in samples of Blue Bell Banana Pudding ice cream pints.

You can read the timeline of events at the FDA web site, and see how the outbreak and the investigation developed. Blue Bell has announced that they are carrying out an “intensive cleaning and training program” at all of its facilities.

The symptoms of listeriosis include high fever, stiff neck, severe headache, nausea, and diarrhea. Some people may only have a mild flu-like illness.

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