# China NMPA Inspection - Wuxi Kaili Pharmaceutical Co., Ltd. - May 12, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/wuxi-kaili-pharmaceutical-co-ltd/98082599-c6f9-4ab0-9ab1-268aaa34a669/
Source feed: China

> China NMPA unannounced inspection for Wuxi Kaili Pharmaceutical Co., Ltd. published May 12, 2018. Wuxi Kaili Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration's Verification Center and the

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Wuxi Kaili Pharmaceutical Co., Ltd.
- Company Name: Wuxi Kaili Pharmaceutical Co., Ltd.
- Publication Date: 2018-05-12
- Product Type: Drugs
- Summary: Wuxi Kaili Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration's Verification Center and the Wuxi Municipal Food and Drug Administration Bureau between March 15 and March 17, 2018. This inspection followed a complaint concerning the company's cimetidine raw material. The investigation uncovered critical deficiencies in laboratory management and production record accuracy. Laboratory findings included identical infrared identification spectra across multiple distinct batches of cimetidine raw material, suggesting data integrity issues. Additionally, essential testing equipment, such as infrared and HPLC hosts, had damaged hard drives with no data backup, and blank yet signed original inspection records were found. Production records revealed that a single operator was documented performing operations simultaneously in different manufacturing sections for various batches of both cimetidine crude and finished products, indicating a systematic failure in oversight and record-keeping. These practices violate the *Good Manufacturing Practice for Pharmaceuticals* (revised in 2010). As a result, the State Food and Drug Administration has mandated the revocation of Wuxi Kaili Pharmaceutical Co., Ltd.'s GMP certificate for cimetidine raw materials and initiated an investigation into the company's suspected illegal activities.

Company: https://www.globalkeysolutions.net/companies/wuxi-kaili-pharmaceutical-co-ltd/c762d161-00b9-4d65-bd5f-cbe80022135f/