FDA 483 - Dae Young Foods Co., Ltd. - March 17, 2017
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Bae Young Foods Co., Ltd., a homeopathic drug manufacturer in Boeun-gun, Korea, was cited for numerous significant deficiencies during an FDA inspection. The firm lacked essential written procedures for annual evaluations, reprocessing, and various production and process controls, indicating a severely underdeveloped quality system. Additionally, observations included inadequate testing of components and containers, poor maintenance of equipment and facilities, and failures in record-keeping and equipment identification.
ID · 5ac5ff7c-9d8c-47f7-b7fb-0d829781bda9