# China NMPA Inspection - Wuhan Hualong Biopharmaceutical Co., Ltd. - June 17, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/wuhan-hualong-biopharmaceutical-co-ltd/0464fd6a-094d-4200-a6ad-5adc1f4b2733/
Source feed: China

> China NMPA unannounced inspection for Wuhan Hualong Biopharmaceutical Co., Ltd. published June 17, 2015. During an unannounced inspection from May 8th to 12th, 2015, the State Food and Drug Administration (SFDA) and Hubei Provincial FDA found significant 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on the unannounced inspection of Wuhan Hualong Biopharmaceutical Co., Ltd.
- Company Name: Wuhan Hualong Biopharmaceutical Co., Ltd.
- Publication Date: 2015-06-17
- Product Type: Drugs
- Summary: During an unannounced inspection from May 8th to 12th, 2015, the State Food and Drug Administration (SFDA) and Hubei Provincial FDA found significant violations at Wuhan Hualong Biopharmaceutical Co., Ltd. The company was cited for failing to manufacture calf blood deproteinized extract injection in accordance with its approved drug standards and processes. A primary issue was the company's unauthorized procurement of calf blood concentrate from an unlicensed facility, rather than producing it in-house as required. To conceal this, Wuhan Hualong Biopharmaceutical fabricated production records, which were inconsistent with actual equipment capacities, such as reaction tank volumes and ethanol recovery data. For instance, recorded feed volumes exceeded the labeled capacity of their denaturation reaction tank, and ethanol recovery amounts were significantly less than what in-house production would yield. Further investigation into the supplier, Shenyang Yuhong District Shuntao Beef Offal Distribution Center, revealed severe deficiencies including unlabeled raw materials, chaotic site management, lack of proper records, and poor hygiene. These actions constitute serious breaches of the Drug Administration Law and Good Manufacturing Practice (GMP) regulations. Consequently, the SFDA mandated the Hubei Provincial FDA to revoke Wuhan Hualong Biopharmaceutical's GMP certificate, order an immediate cessation of production, initiate a recall of all affected products, and pursue legal action for the discovered illegal activities.

Company: https://www.globalkeysolutions.net/companies/wuhan-hualong-biopharmaceutical-co-ltd/0d079793-d837-44b9-8123-0fc65ec93721/