China NMPA Drug Inspection - Hebei Union Pharmaceutical CO., LTD. - Olopatadine Hydrochloride Eye Drops

The Shanghai Municipal Drug Administration (SMDA) issued its 2019 Issue 8 Drug Quality Sampling Inspection Announcement on October 18, 2019, detailing the findings of inspections conducted across various drug production, operation, and use units. The comprehensive review aimed to enhance market order and ensure the quality and safety of marketed drugs. Multiple companies, including Suzhou Boyuan Pharmaceutical Co., Ltd., Tongling Hetian Traditional Chinese Medicine Pieces Co., Ltd., and Anhui Fengyuan Tongling Traditional Chinese Medicine Pieces Co., Ltd., were identified with non-compliant products. The primary issues, predominantly affecting Traditional Chinese Medicine (TCM) processed slices, encompassed failures related to product 'Properties' (e.g., appearance, processing quality), presence of 'Aflatoxin,' and unsuitable 'Moisture' or 'Impurities.' Specific modern drugs also showed 'Visible foreign matter' and deficiencies in 'Content Determination.' These violations contravened standards outlined in the 2015 Edition of the Chinese Pharmacopoeia, the 2008 Edition of the Shanghai Processing Regulations, and other National Drug Standards. The SMDA mandates that all involved entities implement immediate control measures, which include suspending sales, discontinuing use, or recalling non-compliant products. Furthermore, companies are required to thoroughly investigate the underlying causes of these deficiencies and take corrective actions to eliminate potential risks and uphold drug safety standards.