# China NMPA Inspection - Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd. - May 16, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/bozhou-haomen-traditional-chinese-medicine-pieces-co-ltd/15fd3172-aa78-47a9-a16a-25ee03d8b285/
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> China NMPA unannounced inspection for Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd. published May 16, 2017. An unannounced inspection of Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd., conducted from March 9-11, 2017, uncovered critical violatio

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd.
- Company Name: Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2017-05-16
- Product Type: Drugs
- Summary: An unannounced inspection of Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd., conducted from March 9-11, 2017, uncovered critical violations of the "Drug Administration Law of the People's Republic of China" and relevant Good Manufacturing Practice (GMP) regulations. Major issues included significant data integrity failures and severe lapses in production and material management.

The company was found to have issued falsified test reports for frankincense raw materials, despite lacking the necessary equipment and capability to perform all required tests, subsequently processing and selling 500 kg of the material. Laboratory computer system times were intentionally altered to align reprinted chromatograms with original reports, indicating potential data manipulation. Furthermore, inspection and sampling records were incomplete, lacking essential information such as batch numbers for reference standards and reviewer signatures.

Inspectors also discovered employees fabricating batch production records on-site, with numerous unbound records provided that lacked crucial production instructions and authorized quality personnel signatures, even though the products were released for sale. Critical batch production records for saffron were entirely absent. Material management was chaotic, characterized by raw materials not being properly recorded in purchase ledgers, a complete absence of inventory cards for processed materials, and severe traceability issues with conflicting origins for various medicinal ingredients. Production site management was also deficient, showing inconsistencies in material usage, discrepancies in production quantities, and missing equipment usage logs.

Consequently, the State Food and Drug Administration ordered the Anhui Provincial Food and Drug Administration to revoke the company's GMP certificates, oversee the recall of all related products, and initiate a comprehensive investigation into the suspected illegal and irregular production activities.

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