FDA 483 - Hubei Kangzheng Pharmaceutical Co., Ltd. - June 21, 2021

An FDA inspection of Hubei Kangzheng Pharmaceutical Co., Ltd. revealed significant deficiencies in the manufacturing of their sterile OTC drug product, Pi yen chin Ophthalmic Redness Reliever Drops. The firm failed to establish aseptic conditions, validate processes and analytical methods, and maintain adequate environmental and equipment controls. These issues collectively raise serious concerns about the sterility, quality, and purity of the drug product distributed to the U.S. market.