# China NMPA Inspection - Jiangxi Pinxin Pharmaceutical Co., Ltd. - December 12, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangxi-pinxin-pharmaceutical-co-ltd/8a4853ac-0731-4a39-84d7-d38ad2e9789d/
Source feed: China

> China NMPA unannounced inspection for Jiangxi Pinxin Pharmaceutical Co., Ltd. published December 12, 2016. An unannounced inspection of Jiangxi Pinxin Pharmaceutical Co., Ltd., conducted by the State Food and Drug Administration and Jiangxi Provincial Food 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiangxi Pinxin Pharmaceutical Co., Ltd.
- Company Name: Jiangxi Pinxin Pharmaceutical Co., Ltd.
- Publication Date: 2016-12-12
- Product Type: Drugs
- Summary: An unannounced inspection of Jiangxi Pinxin Pharmaceutical Co., Ltd., conducted by the State Food and Drug Administration and Jiangxi Provincial Food and Drug Administration from November 4-6, 2016, revealed significant violations of pharmaceutical manufacturing regulations. Key issues identified included an unstable quality management team, with personnel changes impacting their ability to effectively oversee quality and product release. The company also failed to adequately manage and maintain its facilities and equipment. Material management was chaotic, lacking traceability for raw materials, excipients, and packaging materials, and procedures for medicinal residue disposal were absent. Furthermore, blank production and inspection records were uncontrolled. Most critically, the inspection found evidence of falsified batch production records for various stages, including pre-processing, extraction, and preparation. The quality control department was also found to have fabricated inspection records for purified water, raw materials, excipients, and finished products, indicating a systemic failure in quality assurance. As a result of these findings, and following a previous inspection, the Jiangxi Provincial Food and Drug Administration revoked the company's GMP certificate in November 2016. Risk control measures, such as product recalls and destructions, were subsequently implemented. The State Food and Drug Administration mandated continued investigation and prosecution by the provincial authority, with a requirement to publicly disclose the outcomes.

Company: https://www.globalkeysolutions.net/companies/jiangxi-pinxin-pharmaceutical-co-ltd/bdb1ef72-0c91-401f-9c5b-1a9deab9a631/