483
Nowcos Co., LtdFDA 483 - Nowcos Co., Ltd - September 06, 2019
Record Details
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.
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ID · b8f67fb5-3ec7-410a-aef0-100790fa7764