# China NMPA Drug Inspection - Shanghai Shangyao Xinyi Pharmaceutical Factory Co., Ltd. - Piracetam tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shanghai-shangyao-xinyi-pharmaceutical-factory-co-ltd/2cb95d86-b111-430b-87c7-2defe6fa4952/
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> China NMPA drug inspection for Shanghai Shangyao Xinyi Pharmaceutical Factory Co., Ltd. published April 28, 2018. Drug: Piracetam tablets. The Henan Provincial Food and Drug Administration issued an announcement on April 28, 2018, detailing inspection finding

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from Henan Provincial Food and Drug Administration Regarding 4 Batches of Substandard Drugs (Issue 4, 2018)
- Company Name: Shanghai Shangyao Xinyi Pharmaceutical Factory Co., Ltd.
- Publication Date: 2018-04-28
- Drug Name: Piracetam tablets
- Inspection Finding: The non-compliant item is appearance.
- Action Taken: Relevant food and drug regulatory authorities are required to take necessary risk control measures such as sealing up, seizing, and suspending the sale of substandard drugs found in random inspections, and to investigate and punish the units that source the samples in accordance with the law.
- Summary: The Henan Provincial Food and Drug Administration issued an announcement on April 28, 2018, detailing inspection findings that identified four batches of substandard drugs from four different manufacturers. These inspections, conducted by various municipal food and drug inspection institutes, revealed non-compliance with the Chinese Pharmacopoeia 2015 Edition, serving as the primary regulatory framework.

Specific violations included Bozhou Huqiao Pharmaceutical Co., Ltd.'s Asarum (batch 1704050382) failing due to substandard volatile oil content, and Shanghai Shangyao Xinyi Factory Co., Ltd.'s Piracetam Tablets (batch 003161206) found to have a substandard appearance. Additionally, Bozhou Jishengtang Traditional Chinese Medicine Pieces Co., Ltd.'s stir-fried Atractylodes lancea (batch 170401) showed excessive moisture content, while Anhui Xiehecheng Pharmaceutical Pieces Co., Ltd.'s Acanthopanax senticosus (batch 16083001) failed on extractives content.

In response, the Henan Provincial Food and Drug Administration directed relevant regulatory departments to implement immediate risk control measures. These actions included sealing, seizing, and suspending sales of the substandard drugs. Furthermore, investigations and penalties were mandated for the units that sourced the samples, ensuring accountability and adherence to established pharmaceutical quality standards.

Company: https://www.globalkeysolutions.net/companies/shanghai-shangyao-xinyi-pharmaceutical-factory-co-ltd/6441b58b-cfbb-40ea-8554-2a00e51c6d2a/