FDA 483 - Waterstone Pharmaceuticals Co., Ltd. - September 29, 2021

Waterstone Pharmaceuticals Co., Ltd, an Active Pharmaceutical Ingredient manufacturer in Tianmen, Hubei, China, was cited for significant deficiencies during an FDA inspection. The inspection revealed a repeat observation regarding poorly maintained manufacturing facilities, including mold, rust, and unsanitary cleaning practices. Additionally, the firm lacked appropriate controls over computerized systems, leading to risks of data manipulation and missing analytical data.