FDA Tosses a Grenade On the Table with Blue Bell 483 Reports

At the end of last week FDA made its 483 Inspectional Observation reports available for the three Blue Bell facilities the Agency inspected following the recent outbreaks and recalls for Listeria in the ice cream. I have read many 483s and most of them do not hold huge surprises – they may describe some pretty bad conditions, but typically one can say from a 483 "that is what I expected." It may not be what the plant personnel expected, but to a food safety person a given observation in a 483 is usually met with an acceptance that someone was not following the rules.

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