# China NMPA Inspection - Huangshi Shixing Pharmaceutical Co., Ltd. - December 23, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/huangshi-shixing-pharmaceutical-co-ltd/1fd785f2-85ca-456a-a356-1f277daeb16a/
Source feed: China

> China NMPA unannounced inspection for Huangshi Shixing Pharmaceutical Co., Ltd. published December 23, 2015. An inspection by the State Food and Drug Administration and Hubei Provincial Food and Drug Administration was conducted at Huangshi Shixing Pharmaceut

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Huangshi Shixing Pharmaceutical Co., Ltd.
- Company Name: Huangshi Shixing Pharmaceutical Co., Ltd.
- Publication Date: 2015-12-23
- Product Type: Drugs
- Summary: An inspection by the State Food and Drug Administration and Hubei Provincial Food and Drug Administration was conducted at Huangshi Shixing Pharmaceutical Co., Ltd. from November 17-20, 2015. The inspection revealed multiple regulatory violations concerning the production and sale of piracetam API. The company failed to provide complete production records, including material purchases and usage, for several batches of piracetam API manufactured at its old factory site. An unlabeled drum of piracetam API, lacking a batch number and status, was also found in inventory. Additionally, Huangshi Shixing Pharmaceutical Co., Ltd. sold 295kg of validation batch product from a new address in June and August 2015 without obtaining the required supplementary registration approval. The company also changed the refining process of piracetam API without conducting a change risk assessment, validation studies, or adhering to proper change control procedures. Consequently, the State Food and Drug Administration has ordered the Hubei Provincial Food and Drug Administration to revoke the company's Good Manufacturing Practice certificate for piracetam raw material and to investigate and penalize the illegal production and operational activities.

Company: https://www.globalkeysolutions.net/companies/huangshi-shixing-pharmaceutical-co-ltd/d57b5abd-9cb2-4ee5-88c3-7a610c0d964d/