# China NMPA Inspection - Liaoning Xinghai Pharmaceutical Co., Ltd. - May 23, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/liaoning-xinghai-pharmaceutical-co-ltd/6edad801-34ba-4128-b72a-7229dd25439b/
Source feed: China

> China NMPA unannounced inspection for Liaoning Xinghai Pharmaceutical Co., Ltd. published May 23, 2018. An unannounced inspection of Liaoning Xinghai Pharmaceutical Co., Ltd., conducted in early 2018 under a drug inspection plan, revealed significant non

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Liaoning Xinghai Pharmaceutical Co., Ltd.
- Company Name: Liaoning Xinghai Pharmaceutical Co., Ltd.
- Publication Date: 2018-05-23
- Product Type: Drugs
- Summary: An unannounced inspection of Liaoning Xinghai Pharmaceutical Co., Ltd., conducted in early 2018 under a drug inspection plan, revealed significant non-compliance with the Good Manufacturing Practice for Pharmaceuticals (2010 Revision) concerning its active pharmaceutical ingredient (aluminum phosphate) production. The inspection identified several critical deficiencies. The designated quality authorized person failed to adequately fulfill responsibilities for finished product release, with review and release functions performed by other personnel. A blank, pre-signed 69-page material inspection report was discovered, indicating a serious lapse in material control. Document management was found to be deficient, as two identical documents were assigned different reference numbers, compromising record integrity. Furthermore, batch production records lacked crucial operational details, with key drying, cooling, stirring, and pre-drying treatment steps, as outlined in standard procedures, not being documented. Consequently, the Liaoning Provincial Food and Drug Administration revoked the company's relevant GMP certificate and initiated an investigation into its illegal and irregular activities. This enforcement action was published on May 22, 2018.

Company: https://www.globalkeysolutions.net/companies/liaoning-xinghai-pharmaceutical-co-ltd/fceb60ca-7e7d-4af5-9b39-45a7164761fe/