FDA 483 - Nowcos Co., Ltd - August 04, 2017

An FDA inspection of Nowcos Co., Ltd in Sejong-si, Korea, revealed extensive deficiencies in their manufacturing operations. The firm failed to maintain adequate records, lacked proper computer system controls and data integrity measures, and did not validate analytical methods or calibrate laboratory instruments. Significant issues were also noted in employee training, quality control unit independence, microbial testing, equipment cleaning, and facility storage conditions, indicating a broad non-compliance with cGMP regulations.