Abbott Laboratories – FDA 483, Sep 24, 2021
An FDA inspection of Abbott Nutrition's infant formula manufacturing facility in Sturgis, MI, revealed significant deficiencies. Observations included unsanitary building conditions with standing water and contaminated equipment, inadequate equipment installation and calibration, and poor personnel hygiene practices. Additionally, the firm failed to properly monitor and document critical processing parameters for thermal processing equipment.
ID · c5c430c3-e00d-46ae-97a4-7681512cbf2d
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