# China NMPA Inspection - Fujian Huitian Biopharmaceutical Co., Ltd. - December 29, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/fujian-huitian-biopharmaceutical-co-ltd/71460282-6101-4160-a261-bac7a0a53bc7/
Source feed: China

> China NMPA unannounced inspection for Fujian Huitian Biopharmaceutical Co., Ltd. published December 29, 2017. Fujian Huitian Biopharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration and Sanming Municipal 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Fujian Huitian Biopharmaceutical Co., Ltd.
- Company Name: Fujian Huitian Biopharmaceutical Co., Ltd.
- Publication Date: 2017-12-29
- Product Type: Drugs
- Summary: Fujian Huitian Biopharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration and Sanming Municipal Food and Drug Administration between November 1st and November 3rd, 2017. The inspection, initiated by a drug sampling, revealed critical violations in the production of gentamicin sulfate tablets. The company illegally procured and utilized gentamicin sulfate raw material that did not comply with the Chinese Pharmacopoeia (2015 edition) standards for tablets distributed in the domestic market. Further serious issues included the forging and replacement of raw material manufacturer labels and inspection reports. Key quality management personnel deliberately substituted inspection samples with compliant ones, thereby falsifying test results. Additionally, management failed to uphold duties when using gentamicin sulfate raw material, originally intended for export to the European Union (BP2002/EP4 standard), in domestically sold tablets. A conflict of interest was also noted, where the QC supervisor simultaneously issued and reviewed raw material inspection reports. These actions represent severe breaches of drug administration laws and regulations. As a result, the company was ordered to recall all affected gentamicin sulfate tablets, undergo investigation and prosecution, face accountability measures, and ensure responsible individuals are penalized.

Company: https://www.globalkeysolutions.net/companies/fujian-huitian-biopharmaceutical-co-ltd/ae0cce61-d6f3-444a-b895-87c0c5d4ba85/