# China NMPA Inspection - Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd. - March 27, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/bozhou-haomen-traditional-chinese-medicine-pieces-co-ltd/3a852ba2-22b7-4495-a70c-d15f76bb79cf/
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> China NMPA unannounced inspection for Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd. published March 27, 2015. From March 2nd to 4th, 2015, a surprise inspection by the State Food and Drug Administration, alongside the Anhui Provincial Food and Drug Administrat

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Anhui Bozhou Guoyuan Traditional Chinese Medicine Pieces Co., Ltd.
- Company Name: Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2015-03-27
- Product Type: Drugs
- Summary: From March 2nd to 4th, 2015, a surprise inspection by the State Food and Drug Administration, alongside the Anhui Provincial Food and Drug Administration, revealed significant violations at Bozhou Guoyuan Traditional Chinese Medicine Pieces Co., Ltd. The primary issues included a severe lack of production, inspection, and warehousing records for multiple batches of traditional Chinese medicine pieces, strongly suggesting the company illegally packaged and sold uninspected products. Additionally, the inspection found evidence of falsified product inspection results, notably the absence of required reference standards for critical tests like thin-layer chromatography for specific medicinal materials. The company also exhibited poor record-keeping for raw material inflows and outflows, inadequate management of retained samples, and a complete failure to provide delivery documentation for sold processed medicinal materials. These actions constituted serious breaches of the *Drug Administration Law* and Good Manufacturing Practice (GMP) regulations. As a result, the Anhui Provincial Food and Drug Administration revoked the company's GMP certificate, ordered an immediate halt to all production and sales, mandated a recall of all sold processed medicinal materials, and initiated procedures to revoke its drug production license. The case has also been referred to public security authorities due to suspected criminal activity.

Company: https://www.globalkeysolutions.net/companies/bozhou-haomen-traditional-chinese-medicine-pieces-co-ltd/df9113d5-2c12-4f64-ab68-0c9827cdd2b3/