FDA 483 - Dae Young Foods Co., Ltd. - March 17, 2017

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.