FDA 483 - Beijing HKKY Medical Tech. Co., Ltd. - July 12, 2019

An FDA inspection of Beijing HKKY Medical Tech. Co., Ltd. in Beijing, a manufacturer of OTC Finished Products, revealed two significant quality control deficiencies. The firm failed to adequately test drug product batches for objectionable microorganisms and lacked proper calibration records for a non-viable particle counter. These issues indicate a lack of robust quality assurance for products shipped to the USA.