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Cake day: June 14th, 2023

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  • Most surprisingly, the inspectors observed barefoot employees working in a sterile area of the facility, where they should have been wearing shoes—plus gowns, gloves, and shoe booties. (The barefoot workers were also not wearing gowns or gloves.) A production manager puzzlingly told FDA inspectors that shoeless work is “standard practice.”

    They were supposed to cover everything including the feet.