# China NMPA Inspection - Shaanxi Pharmaceutical Holding Group Biological Products Co., Ltd. - March 29, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/shaanxi-pharmaceutical-holding-group-biological-products-co-ltd/51112f2c-72c7-4ebd-99f7-44e9b2e584e5/
Source feed: China

> China NMPA unannounced inspection for Shaanxi Pharmaceutical Holding Group Biological Products Co., Ltd. published March 29, 2016. An inspection of Shaanxi Pharmaceutical Holding Group Biological Products Co., Ltd. was conducted by the State Food and Drug Administration from Septe

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Shaanxi Pharmaceutical Holding Group Biological Products Co., Ltd.
- Company Name: Shaanxi Pharmaceutical Holding Group Biological Products Co., Ltd.
- Publication Date: 2016-03-29
- Product Type: Drugs
- Summary: An inspection of Shaanxi Pharmaceutical Holding Group Biological Products Co., Ltd. was conducted by the State Food and Drug Administration from September 23-25, 2015. The inspection identified serious non-compliance with the Good Manufacturing Practice for Pharmaceuticals (2010 revision), indicating a high risk to the production of lyophilized powder injections. Key violations included the company's inappropriate use of a GMP-certified lyophilized powder injection production line (Grade B+A cleanroom) for manufacturing transfer factor capsule raw powder, applying lower Grade C and D cleanroom control requirements. This practice, stemming from prolonged inactivity in lyophilized powder injection production, created a significant risk of contamination and cross-contamination. Furthermore, the company failed to perform required simulated culture medium filling tests on its lyophilized powder injection line. The last test was on January 13, 2014, falling short of the mandated six-month frequency, thereby jeopardizing aseptic control capabilities. Quality control deficiencies were also noted, specifically the absence of graded access accounts for high-performance liquid chromatography and gas chromatography, which compromised data security. Additionally, a batch of mannitol (361503014) was not tested for related substances according to established quality standards. As a result of these findings, the State Food and Drug Administration deemed the company's lyophilized powder injection production non-compliant and high-risk. The Shaanxi Provincial Food and Drug Administration was ordered to revoke the company's GMP certificate for lyophilized powder injections, mandate a halt in production, and launch a full investigation.

Company: https://www.globalkeysolutions.net/companies/shaanxi-pharmaceutical-holding-group-biological-products-co-ltd/e6a370e6-56d0-4074-9d14-1e9bf5127d64/