# China NMPA Inspection - Anhui Guanghe Traditional Chinese Medicine Co., Ltd. - April 17, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/anhui-guanghe-traditional-chinese-medicine-co-ltd/7eff0949-e89c-4d67-be0e-43ffddd6099c/
Source feed: China

> China NMPA unannounced inspection for Anhui Guanghe Traditional Chinese Medicine Co., Ltd. published April 17, 2015. Anhui Guanghe Traditional Chinese Medicine Co., Ltd. underwent an unannounced inspection by the State Food and Drug Administration and the Anhui Provi

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Anhui Guanghe Traditional Chinese Medicine Co., Ltd.
- Company Name: Anhui Guanghe Traditional Chinese Medicine Co., Ltd.
- Publication Date: 2015-04-17
- Product Type: Drugs
- Summary: Anhui Guanghe Traditional Chinese Medicine Co., Ltd. underwent an unannounced inspection by the State Food and Drug Administration and the Anhui Provincial Food and Drug Administration between March 28 and April 1, 2015. The inspection revealed significant operational deficiencies and misconduct. Key violations included disorganized production management, characterized by an unclean workshop, lack of cleanliness status markings on equipment, improper storage of medicinal slices and raw materials like wolfberry (which required cool storage), and incorrect segregation of unqualified products. More critically, the company was found to have falsified production and inspection records, with numerous batch production and product inspection records missing for several items. Evidence suggested these records were fabricated to facilitate the illegal production and sale of traditional Chinese medicine decoction pieces, specifically through issuing factory inspection reports to Shenzhen Fohai Traditional Chinese Medicine Co., Ltd. without corresponding internal documentation. These actions constituted serious violations of the *Drug Administration Law* and Good Manufacturing Practice (GMP) regulations. Consequently, the Anhui Provincial Food and Drug Administration revoked the company's GMP certificate, ordered an immediate cessation of production, mandated the recall of all related products, and initiated legal investigations. Cases with suspected criminal elements were referred to public security authorities for further action.

Company: https://www.globalkeysolutions.net/companies/anhui-guanghe-traditional-chinese-medicine-co-ltd/f0558122-5599-494d-a3e7-a7671faaedd4/