# China NMPA Inspection - Henan Kanghua Pharmaceutical Co., Ltd. - May 02, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/henan-kanghua-pharmaceutical-co-ltd/e3661666-9252-43c8-8386-fcb2c8d28f0f
Source feed: China

> China NMPA unannounced inspection for Henan Kanghua Pharmaceutical Co., Ltd. published May 02, 2017. An unannounced inspection of Henan Kanghua Pharmaceutical Co., Ltd., conducted from March 6-8, 2017, by the State Food and Drug Administration and Hen

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Henan Kanghua Pharmaceutical Co., Ltd.
- Company Name: Henan Kanghua Pharmaceutical Co., Ltd.
- Publication Date: 2017-05-02
- Product Type: Drugs
- Summary: An unannounced inspection of Henan Kanghua Pharmaceutical Co., Ltd., conducted from March 6-8, 2017, by the State Food and Drug Administration and Henan Provincial Food and Drug Administration, uncovered significant violations of the 'Drug Administration Law of the People's Republic of China' and relevant Good Manufacturing Practice (GMP) regulations. Major issues included severe deficiencies in material management, such as conflicting paper and electronic inventory records, questionable origins of purchased medicinal herbs due to inconsistent certification stamps, and inadequate warehouse capacity. Production management was also found to be lax, with standard operating procedures absent from production areas, inaccurate batch records, and deviations from established process procedures, particularly in the production of 'Huoxiang Zhengqi Wan.' Furthermore, facility and equipment capacity were deemed insufficient for the daily volume of materials processed. Significant document control failures were identified, including readily accessible blank production records, uncontrolled document templates on employee computers, and unretracted obsolete quality standard versions. As a result, the Henan Provincial Food and Drug Administration revoked the company's GMP certificates. The State Food and Drug Administration has instructed the provincial authority to oversee the recall of relevant products and to investigate and prosecute the company for its suspected illegal and irregular production activities.

Company: https://www.globalkeysolutions.net/companies/henan-kanghua-pharmaceutical-co-ltd/65fe6acd-7740-40b0-854c-ef43a01a3d24