FDA 483 - Barox Co., Ltd. - May 18, 2018

Barox Co., Ltd., a relabeler of OTC drug products in Seongnam-si, Korea, was cited for significant deficiencies in its quality system. The inspection revealed a pervasive lack of written procedures across critical operations, including quality control, production, labeling, and complaint handling. Additionally, employees, including the Quality Control Unit, were found to lack adequate training in current Good Manufacturing Practices and required procedures, and the firm failed to establish procedures and testing for objectionable microorganisms in its non-sterile drug products.