FDA 483 - Jiangsu NHWA Pharmaceutical Co., Ltd. - April 05, 2019

Jiangsu Nhwa Pharmaceutical Co., Ltd, an API manufacturer in Xuzhou, China, received a Form 483 for multiple significant deficiencies. The inspection revealed issues with scientifically unsound stability testing procedures and inadequate investigations into product failures and complaints. Additionally, the firm's laboratory investigation procedures, API reprocessing system, and laboratory instrument control software validation were found to be insufficient.