# China NMPA Inspection - Shanghai Qing'an Pharmaceutical Group Suzhou Pharmaceutical Co., Ltd. - January 06, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/shanghai-qingan-pharmaceutical-group-suzhou-pharmaceutical-co-ltd/7bbcd7b1-bd71-40eb-ad48-f5eccb10ac64/
Source feed: China

> China NMPA unannounced inspection for Shanghai Qing'an Pharmaceutical Group Suzhou Pharmaceutical Co., Ltd. published January 06, 2017. Shanghai Qing'an Pharmaceutical Group Suzhou Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administra

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shanghai Qing'an Pharmaceutical Group Suzhou Pharmaceutical Co., Ltd.
- Company Name: Shanghai Qing'an Pharmaceutical Group Suzhou Pharmaceutical Co., Ltd.
- Publication Date: 2017-01-06
- Product Type: Drugs
- Summary: Shanghai Qing'an Pharmaceutical Group Suzhou Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration from November 14-16, 2016. The inspection uncovered critical deviations from regulatory standards and internal procedures, primarily occurring before the company's production suspension on January 1, 2016, pending a license renewal.

Key issues included the company's failure to adhere to statutory process requirements for Scutellaria baicalensis extract powder, an ingredient in Zhenhuang Capsules. Specifically, the decoction process lacked effective filtration, directly contradicting the *Chinese Pharmacopoeia* and *Traditional Chinese Medicine Preparations* guidelines. Additionally, material management was found to be chaotic, characterized by untraceable alum sources, inconsistent supplier documentation for Scutellaria baicalensis purchases, unlabeled raw materials in storage, and inadequate storage conditions with high humidity. Furthermore, production records exhibited inaccuracies, with operator signature times differing from attendance logs.

In response to these significant gaps from Good Manufacturing Practice (GMP) requirements, regulatory authorities have mandated an investigation and prosecution by the Anhui Provincial Food and Drug Administration for non-compliant Zhenhuang capsule production. Required actions include recalling all affected products, a continued prohibition on production until the company achieves GMP certification, and strengthened daily supervision.

Company: https://www.globalkeysolutions.net/companies/shanghai-qingan-pharmaceutical-group-suzhou-pharmaceutical-co-ltd/75212414-e3b3-44fd-9922-424302661aba/