FDA 483 - First Time US Generics LLC - February 15, 2018

During an FDA inspection, First Time US Generics LLC in Broomall, PA, was cited for deficiencies in their equipment cleaning and maintenance procedures. The firm lacked written procedures for documenting quality issues related to maintenance, as evidenced by an unassessed damaged tablet press. This indicates a failure in maintaining equipment in a state of control and ensuring product quality.