483
Kyongbo Pharmaceutical Co., Ltd.FDA 483 - Kyongbo Pharmaceutical Co., Ltd. - December 02, 2019
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Record Details
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.
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ID · 724a8112-263e-48b8-b476-8814f8a16da8