FDA 483 - American Cleaning Solutions - March 28, 2022

An FDA inspection of American Cleaning Solutions in Long Island City, NY, revealed numerous significant deficiencies in their manufacturing practices for hand rub and sanitizer products. The firm failed to follow written procedures, released out-of-specification products, lacked essential documentation, and operated with unqualified equipment and untrained personnel. Many of these critical observations were repeats from a previous 2016 inspection, indicating a persistent lack of compliance with cGMP regulations.