# China NMPA Inspection - Shijiazhuang Pharmaceutical Group Hebei Yongfeng Pharmaceutical Co., Ltd. - April 18, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/shijiazhuang-pharmaceutical-group-hebei-yongfeng-pharmaceutical-co-ltd/ed283eb9-35b6-4775-9210-c77533f50e8a/
Source feed: China

> China NMPA unannounced inspection for Shijiazhuang Pharmaceutical Group Hebei Yongfeng Pharmaceutical Co., Ltd. published April 18, 2016. An unannounced inspection of Shijiazhuang Pharmaceutical Group Hebei Yongfeng Pharmaceutical Co., Ltd., conducted from March 24-27, 2016, by the Verif

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shijiazhuang Pharmaceutical Group Hebei Yongfeng Pharmaceutical Co., Ltd.
- Company Name: Shijiazhuang Pharmaceutical Group Hebei Yongfeng Pharmaceutical Co., Ltd.
- Publication Date: 2016-04-18
- Product Type: Drugs
- Summary: An unannounced inspection of Shijiazhuang Pharmaceutical Group Hebei Yongfeng Pharmaceutical Co., Ltd., conducted from March 24-27, 2016, by the Verification Center of the State Food and Drug Administration and the Hebei Provincial Food and Drug Administration, uncovered multiple critical violations. The inspection was triggered by evaluative sampling. Key issues included the suspected use of counterfeit or substandard medicinal materials, evidenced by discrepancies in active ingredient content (aloin, baicalin, and gentianoside) in aloe vera and Tongqiao Erlong Pills. Furthermore, the company made an unauthorized alteration to its sterilization process, switching from moist heat to irradiation for Chinese herbal medicine powders without proper evaluation, change control records, or adequate process documentation, violating the *Technical Guidelines for Irradiation Sterilization of Traditional Chinese Medicine*. Additionally, raw material inspection records were found to be inaccurate, with evidence of chromatogram manipulation for Scutellaria baicalensis. These actions violated the *Drug Administration Law* and relevant Good Manufacturing Practice (GMP) regulations. Consequently, the company was ordered to immediately cease production, have its GMP certificates revoked, investigate the production and sales of Tongqiao Erlong Wan, recall all affected products, and face further investigation.

Company: https://www.globalkeysolutions.net/companies/shijiazhuang-pharmaceutical-group-hebei-yongfeng-pharmaceutical-co-ltd/d91150f3-819e-407b-a895-9ae18b2c8711/