China NMPA Drug Inspection - Qilu Pharmaceutical Co., Ltd. - Cephalexin for Injection

On January 26, 2018, the State Food and Drug Administration (SFDA) announced the findings from tests conducted by nine drug testing institutions, identifying nine batches of substandard drugs from nine different manufacturers. Key companies implicated included Shenzhen Hanyu Pharmaceutical Co., Ltd., Changchun Renmin Pharmaceutical Group Co., Ltd., Harbin Dayang Pharmaceutical Co., Ltd., Beijing Tongrentang Technology Development Co., Ltd. Pharmaceutical Factory, and Qilu Pharmaceutical Co., Ltd., among others.The inspections revealed significant quality control deficiencies across a range of products. Violations included failures in content determination for Somatostatin for Injection and Cephalexin for Injection, unacceptable weight differences in Anwei Tablets, and insufficient potency for Pepsin Granules. Other issues involved product appearance, disintegration time, content variation in several capsule and granule formulations, and improper paste content for Musk Bone-Strengthening Plaster. These findings indicated non-compliance with established standards, such as the *Pharmacopoeia of the People's Republic of China* and various Ministry of Health Drug Standards.In response, provincial food and drug administrations took immediate control measures, including sealing and seizing the affected products. The implicated companies were mandated to suspend sales, recall the substandard items, and implement corrective actions. Furthermore, the SFDA directed provincial authorities to investigate these illegal activities under Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*, requiring public disclosure of resolution outcomes within three months and prompt reporting to the SFDA.