News about GMP/cGMP

31.08.2018

Six Asian Drug Manufacturers refuse FDA Inspection

The US Food and Drug Administration, FDA, has added six Asian drug manufacturers to its import alert list this month, that refused a planned inspection of the FDA.

The newly listed Asian manufacturers are from China (4), India (1) and South Korea (1):

  • Chifeng Wanze Pharmaceutical Co., China
  • Guangdong Jiaying Pharmaceutical, Ltd., China
  • Shenyang Funing Pharmaceutical Co., China
  • Guangdong Guangliang Industry Co., China
  • Gpt Pharmaceuticals Private, India
  • Dongkook Pharmaceutical Co., South Korea

The so called “Red List” identifies firms that have offered FDA-regulated articles for import into the United States and yet refused to allow the completion of an FDA inspection of their foreign establishment for the purpose of determining its conditions and compliance with applicable laws and regulations. Refusing to permit entry or inspection through FDA’s personnel always leads to the impression that something is wrong. It is furthermore strongly suspected that the products manufactured, processed or packaged are adulterated.

The reasons why these pharmaceutical manufacturers refused the inspections is still unknown.


Source:

FDA: Import Alert 99-32

 



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