China NMPA Inspection - Wuhan Wujing Pharmaceutical Co., Ltd. - July 03, 2018

An unannounced inspection of Wuhan Wujing Pharmaceutical Co., Ltd. by the Verification Center of the State Food and Drug Administration, prompted by a drug tracking inspection plan, revealed significant compliance failures. While specific inspection dates are not provided, the report was published on July 3, 2018, addressing issues related to product batches from late 2016 and early 2017. The primary violations centered on the production and quality control of Sodium Cromoglycate Eye Drops, which significantly deviated from the "Good Manufacturing Practice for Pharmaceuticals (2010 Revision)" (GMP). Key issues included inaccurate record-keeping and an ineffective quality management system. A major concern was the unauthorized reworking of two batches of sodium cromoglycate eye drops (16120406 and 17010403) that failed initial inspections due to visible foreign matter. The company failed to thoroughly investigate the root cause of the non-compliance or assess the impact of the rework process on product quality. Furthermore, essential steps of the rework, such as product release, opening boxes, and label removal, were not properly documented. As a result, the Hubei Provincial Food and Drug Administration has been directed to revoke the company's relevant GMP certificates. Additionally, the company is subject to further investigation and legal action regarding its identified illegal and irregular activities.