FDA 483 - Enprani Co., Ltd. - March 11, 2019

An FDA inspection of Enprani Co., Ltd., an OTC drug manufacturer in Incheon Jung, South Korea, revealed significant deficiencies across multiple areas of its operations. The firm was cited for inadequate laboratory records and controls, a lack of proper quality unit oversight, incomplete batch production records, and insufficient process validation. These observations indicate a failure to adhere to current good manufacturing practices, potentially impacting the quality and integrity of their drug products.