# China NMPA Inspection - Guangdong Danxia Biopharmaceutical Co., Ltd. - April 21, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/guangdong-danxia-biopharmaceutical-co-ltd/5ee26889-8906-4753-98eb-95ed640a737e/
Source feed: China

> China NMPA unannounced inspection for Guangdong Danxia Biopharmaceutical Co., Ltd. published April 21, 2017. An unannounced inspection conducted by the State Food and Drug Administration and Guangdong Provincial Food and Drug Administration on February 14-16,

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Guangdong Danxia Biopharmaceutical Co., Ltd.
- Company Name: Guangdong Danxia Biopharmaceutical Co., Ltd.
- Publication Date: 2017-04-21
- Product Type: Drugs
- Summary: An unannounced inspection conducted by the State Food and Drug Administration and Guangdong Provincial Food and Drug Administration on February 14-16, 2017, at Guangdong Danxia Biopharmaceutical Co., Ltd. revealed significant compliance issues. The inspection, initiated due to a complaint, uncovered discrepancies primarily concerning human serum albumin products. Key violations included concerns about the authenticity of registration data for human serum albumin. Stability studies for nine production batches showed actual aluminum ion levels exceeding the pharmacopoeia standard of 200 5g/L during long-term and accelerated testing, directly contradicting the data submitted for product registration. Furthermore, the reliability of post-marketing stability data was compromised. The company's records showed inconsistencies between actual and reported aluminum ion detection results, with real values often failing to meet the required standards. Investigations also found evidence of data manipulation, such as modifying sample names and deleting test records for retesting. Specifically, batch 20130503 recorded an actual aluminum ion level of 408 5g/L, while reporting only 143 5g/L. Additionally, actual prokaryotic release enzyme activator (PKA) content was inconsistent with recorded values and failed to meet pharmacopoeia requirements. These findings indicate serious violations of the "Drug Administration Law of the People's Republic of China." As a result, the Provincial Drug Administration was instructed to revoke the company's "Drug GMP Certificate." Further actions include launching an investigation into the company's illegal practices and overseeing the implementation of risk control measures for all affected products.

Company: https://www.globalkeysolutions.net/companies/guangdong-danxia-biopharmaceutical-co-ltd/216ea1bc-c798-4cee-b673-f5ef7538c22c/