# China NMPA Inspection - Jiangsu 707 Natural Pharmaceutical Co., Ltd. - December 05, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangsu-707-natural-pharmaceutical-co-ltd/66cf536c-a0ea-49a4-9fdf-d73545880a47/
Source feed: China

> China NMPA unannounced inspection for Jiangsu 707 Natural Pharmaceutical Co., Ltd. published December 05, 2018. An inspection of Jiangsu 707 Natural Pharmaceutical Co., Ltd., detailed in a report published November 30, 2018, revealed significant non-compliance w

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## Details

- Record Type: CHINA_INSPECTION
- Title: Follow-up Inspection Report on Jiangsu 707 Natural Pharmaceutical Co., Ltd.
- Company Name: Jiangsu 707 Natural Pharmaceutical Co., Ltd.
- Publication Date: 2018-12-05
- Product Type: Drugs
- Summary: An inspection of Jiangsu 707 Natural Pharmaceutical Co., Ltd., detailed in a report published November 30, 2018, revealed significant non-compliance with the Good Manufacturing Practice for Pharmaceuticals (2010 Revision), particularly concerning their Agarwood Qi-regulating Pills.The primary issues identified were systemic failures in material management, production operations, and deviation investigations. In material management, the company exhibited irregular practices, including contaminated ethanol with foreign matter and improper sealing, as well as uncontrolled storage of materials like corn starch and ethanol in unauthorized areas. Critical intermediate products, specifically Jin Dan tablet granules requiring cold storage (2-8℃), were stored at ambient temperatures (18-26℃) due to insufficient facilities. Additionally, Jindan tablets exceeded their maximum storage time, and several bags of intermediate products were found unlabeled.Production operations demonstrated a clear inability to prevent batch mixing, with different batches of Jin Dan tablets being mixed during packaging, a failure attributed to inadequate verification by operators and QA personnel. The company also failed to conduct timely and thorough investigations into deviations. This included releasing a medicinal material (Amomum villosum) after a retest, despite an initial Out-of-Specification result, without prior investigation. Furthermore, an extended storage period for mixed powder of Agarwood Qi-Regulating Pills went uninvestigated.As a result of these serious deficiencies, the Jiangsu Provincial Drug Administration has been directed to revoke the company's relevant GMP certificates and initiate further investigations and actions.

Company: https://www.globalkeysolutions.net/companies/jiangsu-707-natural-pharmaceutical-co-ltd/16927858-622a-48f4-904b-41b2114327d2/