# China NMPA Inspection - Hunan Jianlang Pharmaceutical Co., Ltd. - December 23, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/hunan-jianlang-pharmaceutical-co-ltd/da492807-f621-4ada-99a1-5c709211e1f1/
Source feed: China

> China NMPA unannounced inspection for Hunan Jianlang Pharmaceutical Co., Ltd. published December 23, 2015. An unannounced inspection of Hunan Jianlang Pharmaceutical Co., Ltd. by the State Food and Drug Administration and the Hunan Provincial Food and Drug 

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Hunan Jianlang Pharmaceutical Co., Ltd.
- Company Name: Hunan Jianlang Pharmaceutical Co., Ltd.
- Publication Date: 2015-12-23
- Product Type: Drugs
- Summary: An unannounced inspection of Hunan Jianlang Pharmaceutical Co., Ltd. by the State Food and Drug Administration and the Hunan Provincial Food and Drug Administration from November 17-20, 2015, uncovered significant regulatory non-compliance. The primary issues revolved around the production and quality management of piracetam raw materials. Inspectors found batch production records and finished product inventory ledgers were inaccurate, showing a substantial discrepancy where sales and usage exceeded recorded production by 53,693 kg since 2014, indicating severe defects in the company's quality system and a failure of personnel responsibilities. The company also engaged in illegal sales practices, directly shipping piracetam raw materials to customers of drug distribution companies, suspected of facilitating improper invoicing. Data integrity was critically compromised, with evidence of selective use of reference chromatograms for product identification. Furthermore, analytical instruments, specifically high-performance liquid chromatographs and gas chromatographs, lacked proper access control, featuring shared login passwords and no audit tracking functions, thereby undermining the reliability of test results. Consequently, the State Food and Drug Administration mandated the Hunan Provincial Food and Drug Administration to revoke Hunan Jianlang Pharmaceutical Co., Ltd.'s Drug GMP Certificate for piracetam raw materials and to pursue further investigation and legal penalties for the identified illegal production and operational activities.

Company: https://www.globalkeysolutions.net/companies/hunan-jianlang-pharmaceutical-co-ltd/1d411ba1-2739-4a99-b10c-b68b355e3826/