# China NMPA Inspection - Hubei Qianjiang Pharmaceutical Co., Ltd. - January 05, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/hubei-qianjiang-pharmaceutical-co-ltd/ac3a37bb-7c23-45b5-980b-7ed04fbe7db8/
Source feed: China

> China NMPA unannounced inspection for Hubei Qianjiang Pharmaceutical Co., Ltd. published January 05, 2017. Hubei Qianjiang Pharmaceutical Co., Ltd. was subjected to a follow-up inspection by the State Food and Drug Administration and Hubei Provincial Food a

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Hubei Qianjiang Pharmaceutical Co., Ltd.
- Company Name: Hubei Qianjiang Pharmaceutical Co., Ltd.
- Publication Date: 2017-01-05
- Product Type: Drugs
- Summary: Hubei Qianjiang Pharmaceutical Co., Ltd. was subjected to a follow-up inspection by the State Food and Drug Administration and Hubei Provincial Food and Drug Administration from October 27-30, 2016. The inspection uncovered multiple significant deviations from the "Drug Administration Law of the People's Republic of China" and relevant Good Manufacturing Practice (GMP) regulations. Major findings included the company's failure to timely and effectively recall products (batch numbers: 140901, 140902, 140903) that failed long-term stability tests, initiating a recall only after significant delay. The company also demonstrated ineffective quality control over purchased cytidine diphosphate choline sodium raw materials, evident from prematurely releasing material before complete testing and failing to conduct Out-of-Specification investigations for spectral discrepancies. Furthermore, the company failed to conduct comprehensive product quality reviews for Citicoline Sodium Injection, maintaining incomplete quality documentation. Process validation for changes like increased production batch size and extended process time limits was deemed insufficient, lacking adequate validation batches and parameter coverage. Critically, quality control inspections showed inconsistencies, such as incorrect HPLC injection volumes manually altered without investigation, missing data in original inspection records, omitted system suitability tests, and the use of unstandardized imported reference materials. Consequently, regulatory authorities mandated the Hubei Provincial Food and Drug Administration to revoke the company's GMP certificate (CN20150016), initiate an investigation into the illegal activities, and supervise the implementation of risk control measures for affected products.

Company: https://www.globalkeysolutions.net/companies/hubei-qianjiang-pharmaceutical-co-ltd/699fe3a9-41dd-437a-a8c7-d9fcf3559d46/