China NMPA Drug Inspection - Sichuan Pharmaceutical Preparations Co., Ltd. - Oxyphenidyl Sodium Capsules

On April 28, 2020, the Shanghai Municipal Drug Administration published the results of its first-quarter drug quality sampling inspections for 2020. The report identified 54 batches of medicinal products and packaging materials that failed to meet safety and quality standards. The inspections were conducted according to the 2015 Edition of the Chinese Pharmacopoeia, the 2008 Shanghai Processing Regulations, and various national pharmaceutical standards. The violations spanned a wide array of issues. Traditional Chinese medicine products from companies such as Anhui Pujian Traditional Chinese Medicine Slices and Shanghai Dedatang Traditional Chinese Medicine frequently failed due to improper processing, insect infestations, and excessive levels of heavy metals or sulfur dioxide. Modern pharmaceuticals also faced scrutiny; for instance, Shanghai Baxter Medical Supplies and Shanghai Xinyi Jinzhu Pharmaceutical produced injections and eye drops containing visible foreign matter. Other failures involved substandard moisture content, weight discrepancies, and excessive solvent residues in pharmaceutical packaging. In response to these findings, the Shanghai Municipal Drug Administration has ordered all involved enterprises to implement immediate risk control measures, including the suspension of sales and the withdrawal of non-compliant products from use. Regulatory departments are also conducting formal investigations and legal proceedings against the cited companies to address the violations and ensure the safety of the drug supply chain.