FDA 483 - Nowcos Co., Ltd - September 06, 2019

Nowcos Co., Ltd, an OTC drug manufacturer in Sejeong-myeon, Sejeong-si, Korea, was cited for ten significant deficiencies during an FDA inspection from September 2-6, 2019. The observations primarily concern inadequate computer system controls, deficient test method validation, lack of cleaning and process validations, and insufficient laboratory controls and record-keeping. Many of these issues were repeat observations from a previous 2017 inspection, indicating persistent non-compliance with GMP regulations.