China NMPA Drug Inspection - Hubei Yitai Pharmaceutical Co., Ltd - Fangji

The Hubei Provincial Drug Administration issued its third Drug Quality Announcement of 2019 on November 28, 2019, detailing the results of provincial drug quality sampling inspections. The inspections identified 38 batches of drugs that failed to meet established quality standards, impacting multiple pharmaceutical and traditional Chinese medicine (TCM) companies. Key manufacturers implicated include Shanxi Huakang Pharmaceutical Co., Ltd., Hunan Hengwei Pharmaceutical Co., Ltd., Chifeng Sailintai Pharmaceutical Co., Ltd., and numerous TCM processing entities across Hubei and Anhui provinces. Inspection dates are reflected in the sampled batch numbers, spanning from 2015 to 2019. Violations were diverse. For finished drug products like Huoxiang Zhengqi Capsules and Jianwei Xiaoshi Tablets, issues included substandard appearance, content variation, weight discrepancies, and failures in disintegration time. Traditional Chinese medicinal herbs and processed slices exhibited widespread non-compliance, with common deficiencies in appearance, incorrect identification (e.g., adulterants, microscopic characteristics), unacceptable total ash levels, pH imbalances, moisture content, and inaccurate active ingredient content. Additionally, some hospital preparations, such as Compound Urea Cream, showed content weight discrepancies. A notable concern was that several implicated manufacturers denied producing the non-compliant batches, indicating potential illicit production or supply chain issues. Operating under the "Drug Administration Law of the People's Republic of China," the announcement mandates city and prefecture market supervision bureaus to thoroughly investigate all non-compliant drugs and related units. Required actions include enforcement, reporting findings to the provincial bureau, tracing the origin of products from unverified manufacturers, and referring suspected criminal cases to public security for prosecution.