FDA 483 - Kyongbo Pharmaceutical Co., Ltd. - December 02, 2019

Kyongbo Pharmaceutical Co., Ltd. in Asan-Si, Korea, an API manufacturer, was inspected from December 2-6, 2019. The inspection revealed significant deficiencies in laboratory controls, specifically concerning data integrity and security for analytical instruments and microbiology laboratory records. These issues indicate a lack of proper controls to ensure data is fully secured and attributable.