# China NMPA Inspection - Xi'an Aslan Pharmaceutical Co., Ltd. - December 28, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/xian-aslan-pharmaceutical-co-ltd/ddfdda98-1821-4dbb-a492-e0392c812935/
Source feed: China

> China NMPA unannounced inspection for Xi'an Aslan Pharmaceutical Co., Ltd. published December 28, 2015. An unannounced inspection of Xi'an Aslan Pharmaceutical Co., Ltd., conducted by the State Food and Drug Administration and Shaanxi Provincial Food and

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Xi'an Aslan Pharmaceutical Co., Ltd.
- Company Name: Xi'an Aslan Pharmaceutical Co., Ltd.
- Publication Date: 2015-12-28
- Product Type: Drugs
- Summary: An unannounced inspection of Xi'an Aslan Pharmaceutical Co., Ltd., conducted by the State Food and Drug Administration and Shaanxi Provincial Food and Drug Administration from September 24-26, 2015, uncovered numerous critical violations. The company was found to be operating in serious breach of the "Drug Administration Law" and Good Manufacturing Practice (GMP) regulations, including specific deviations from the 2010 Chinese Pharmacopoeia.

Key findings included suspected unauthorized alteration of the production process for refined coronary heart disease tablets, specifically the addition of unapproved ingredients and deviation from stipulated extraction methods. The source of a critical extract (Dalbergia odorifera) was unknown, and necessary extraction equipment was absent. Furthermore, the company's production and quality management system was critically deficient, lacking essential documentation such as raw material sourcing, inspection, warehousing, sales, and batch production records.

Other significant issues involved unauthorized changes to warehouse layouts, failure to properly implement finished product release procedures, and poor record-keeping practices. The inspection also revealed insufficient testing capabilities due to a lack of required instruments, leading to untested product components. Material discrepancies for active ingredient extracts were noted, with significant quantities unaccounted for. Additional concerns included inadequate supplier evaluation, poor material traceability, unauthorized outsourcing of extraction, and non-adherence to cleanroom protocols and internal quality standards.

As a result of these systemic failures, the regulatory authorities mandated severe corrective actions. The Shaanxi Provincial Food and Drug Administration was ordered to revoke Xi'an Aslan Pharmaceutical Co., Ltd.'s GMP certificate, compel the company to cease all production, initiate a recall of affected products, and pursue legal investigation and punishment for all identified illegal activities.

Company: https://www.globalkeysolutions.net/companies/xian-aslan-pharmaceutical-co-ltd/2c60c924-29d4-4b83-ac74-fee34a5bc653/