# China NMPA Inspection - Harbin Shengtai Biopharmaceutical Co., Ltd. - March 01, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/harbin-shengtai-biopharmaceutical-co-ltd/9619945d-7e91-438f-9b1a-a3a4e32737d5/
Source feed: China

> China NMPA unannounced inspection for Harbin Shengtai Biopharmaceutical Co., Ltd. published March 01, 2016. An unannounced inspection of Harbin Shengtai Biopharmaceutical Co., Ltd. (Shengtai Company) was conducted by the State Food and Drug Administration fr

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## Details

- Record Type: CHINA_INSPECTION
- Title: Follow-up Inspection Report on Harbin Shengtai Biopharmaceutical Co., Ltd.
- Company Name: Harbin Shengtai Biopharmaceutical Co., Ltd.
- Publication Date: 2016-03-01
- Product Type: Drugs
- Summary: An unannounced inspection of Harbin Shengtai Biopharmaceutical Co., Ltd. (Shengtai Company) was conducted by the State Food and Drug Administration from November 17-19, 2015. The inspection revealed several critical deficiencies, primarily concerning quality control and data integrity.
A significant issue identified was that the total saponins of Panax notoginseng, a key ingredient in Shengtai Company's XueShuanTong injection, did not comply with approved quality standards. The supplier's quality specifications differed substantially from those of Shengtai Company, particularly regarding extraction solvent concentration and content control.
Further findings highlighted severe data management deficiencies. Electronic data for equipment re-validation was not backed up, and shared passwords for analytical instruments compromised data integrity, failing to prevent unauthorized modifications. Additionally, some re-validation reports contained handwritten data instead of original printouts, and critical data was omitted. Laboratory records were also found to be incomplete and unstandardized, lacking essential details like equipment numbers or sterilization times. The company also failed to investigate observed deviations in stability study data for XueShuanTong Injection.
These actions violated the "Drug Administration Law" and Good Manufacturing Practice (GMP) regulations. Consequently, the State Food and Drug Administration mandated that the Heilongjiang Provincial Food and Drug Administration initiate an immediate investigation. Shengtai Company was ordered to cease production of XueShuanTong Injection, and its registration for using Panax notoginseng total saponins extract was revoked. The company must also perform a comprehensive risk assessment for related products, implement necessary risk control measures, and face investigations regarding its violations.

Company: https://www.globalkeysolutions.net/companies/harbin-shengtai-biopharmaceutical-co-ltd/4a2512f5-07d3-4351-8efa-9b159f16bbb9/