I must admit that I have been focused on the disasters that are the recently produced 483 Inspection Reports from the three Blue Bell ice cream plants, that I hade not had a chance to review the recently received (and not publically available) 483 Inspection Report and the Establishment Inspection Report done after the CDC announcement of a 12 state, 35 person (including 7 deaths) Listeria outbreak linked to caramel apples.
Here are the 483 findings:
Food that has been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Listeria positives were found on food contact surfaces: black polishing brush, red drying brushes, auto line REDACTED lane, main packing line drain between the north and south flumes and inside area of non-painted Bidart wooden bin.
Direct food contact areas of packing equipment constructed and/or maintained in a manner so that they cannot be properly cleaned and sanitized.
Here is the full Establishment Inspection Report with a lot of redaction. A couple of things jumped out at me:
“sanitation training was not documented.”
“no cleaning and sanitation is conducted between packaging of lots.”
“conditions observed may, after further review by the Agency, be considered to be violations of the Food, Drug and Cosmetic Act or other statutes and legal sanctions available to the FDA my include seizure, injunction, civil money penalties and prosecution.”
“the Pulsed-field gel electrophoresis (PFGE) patterns of the seven positive Listeria monocytogenes environmental swabs matched the PFGE patterns from outbreak patient isolates.”
Another unnecessary, tragic outbreak.