Members of the US House of Representatives directed a letter to the FDA Commissioner Margret A. Hamburger. In this letter they raise several questions with regard to the FDA inspections at Chinese Heparin manufacturers - specifically relative to the manufacturer Chongqing Imperial as well as to three other companies (Hangzhou Ruihua Biochemical products, Changzhou Qianhong Biopharma and Yantai Dongcheng Biochemicals). The letter demonstrates what challenges authority inspectors but also auditors are facing during a visit of Chinese manufacturers. Following is a summary of the issues addressed with regard to the FDA's inspection of the Heparin manufacturers:
At the end of the very detailed letter the FDA is asked for a statement. The authority is requested to demonstrate whether and how it will cooperate with the Chinese authority SFDA to finally clear up the Heparin affair.
The USA is systematically working off the Heparin case to ensure a secure GMP supervision for the future. In Europe the Heparin case has alerted the authorities as well. However, there is no comparable analysis of previous GMP inspections at the affected Chinese Heparin manufacturers.
Here you can read the letter to the FDA in full length.
Dr Gerhard Becker
On behalf of the European Compliance Academy (ECA)