King Bio Inc. – FDA 483, Aug 12, 2021

An FDA inspection of King Bio Inc. in Asheville, NC, from August 2-12, 2021, resulted in a Form 483 listing seven observations, including three repeat observations. The findings highlight significant deficiencies across the firm's quality system, encompassing inadequate investigation procedures, a lack of process validation, insufficient employee training, and issues with equipment qualification, material inventory, component identity testing, and hold time studies. These observations collectively indicate a need for improved controls and adherence to good manufacturing practices for drug product production.