China NMPA Drug Inspection - Jinan Fifth People"s Hospital - Boric acid ear drops

The Shandong Provincial Food and Drug Administration (SPFDA) released an announcement on June 15, 2017, later re-published on November 18, 2019, detailing the findings of quality sampling inspections. These inspections identified eight batches of substandard drugs from various manufacturers and medical institutions, evaluated against the "Shandong Provincial Medical Institution Preparation Standards" and the "Chinese Pharmacopoeia" (2010 and 2015 editions).

Key issues included failures in inspection parameters, appearance, identification, minimum filling, weight difference, dissolution, visible foreign matter, and content uniformity. Companies implicated were medical institutions like Jinan Fifth People's Hospital, Shandong Provincial Acupuncture Hospital, and Dongjia Orthopedic Clinic, alongside pharmaceutical companies such as Jilin Changheng Pharmaceutical Co., Ltd., Shandong Renhetang Pharmaceutical Co., Ltd., Linzhou Yashen Pharmaceutical Co., Ltd., and Shandong Liangfu Pharmaceutical Co., Ltd.

In response, municipal food and drug administrations have implemented immediate control measures, including product sealing, seizure, sales suspension, and recalls. Investigations into the non-compliant manufacturers and sampled units are ongoing. The SPFDA mandated that relevant bureaus enhance daily supervision, ensure companies identify root causes, and implement robust rectification measures to eliminate potential quality risks.