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