# China NMPA Inspection - Harbin Sanlian Pharmaceutical Co., Ltd. - July 03, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/harbin-sanlian-pharmaceutical-co-ltd/c38be4f2-34b5-4261-94c1-3fe3782f323f/
Source feed: China

> China NMPA unannounced inspection for Harbin Sanlian Pharmaceutical Co., Ltd. published July 03, 2018. An inspection conducted by the State Food and Drug Administration's Verification Center, as part of a drug tracking plan, revealed significant non-com

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Harbin Sanlian Pharmaceutical Co., Ltd.
- Company Name: Harbin Sanlian Pharmaceutical Co., Ltd.
- Publication Date: 2018-07-03
- Product Type: Drugs
- Summary: An inspection conducted by the State Food and Drug Administration's Verification Center, as part of a drug tracking plan, revealed significant non-compliance at Harbin Sanlian Pharmaceutical Co., Ltd. The inspection, published on July 3, 2018, focused on the company's vinpocetine injection and gallate series products. The primary issues identified were inconsistencies between the approved registration and the current manufacturing processes for vinpocetine for injection (30mg).

Specifically, the formulation for vinpocetine for injection showed a deviation in excipient dosage, with mannitol reduced from 270mg to 75mg per vial. Furthermore, the manufacturing process itself, including preparation, sterilization filtration, and lyophilization, differed from the originally registered and approved procedures. These discrepancies constitute a serious violation of the Good Manufacturing Practice for Pharmaceuticals (2010 Revision).

As a result of these findings, the Heilongjiang Provincial Food and Drug Administration was instructed to revoke Harbin Sanlian Pharmaceutical Co., Ltd.'s relevant Good Manufacturing Practice certificate. Additionally, the provincial authority is required to investigate and take appropriate legal action regarding the identified illegal and irregular activities to ensure regulatory compliance and product quality standards.

Company: https://www.globalkeysolutions.net/companies/harbin-sanlian-pharmaceutical-co-ltd/a08059c8-3212-4dab-99b1-c1275ce7c180/