FDA Inspections in China - Consequences from the Heparin Case

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:

  • Obviously the inspectors were insufficiently informed about Chongqing Imperial. The FDA had already issued an import alert. The import of a delivery was already blocked by Customs; in addition there is suspicion that the company runs a Canadian sham company.
  • The production site inspected by the inspectors was located a one hour drive away from the actual company headquarter and had a different company name. This should have made the inspectors suspicious.
  • On site there was no independent translator available. Communication was managed exclusively by the president of Chongqing Imperial.
  • The inspectors did not know the difference between Heparin raw product and pure Heparin finished product. Accordingly inadequate was their comprehension of single stations, paths as well as the entire supply chain for raw and pure Heparin.
  • Prior to the inspection there was no intention to cooperate with the Chinese Authority SFDA. They had sealed containers and production areas of the other three above mentioned Heparin manufacturers before. During their visit the FDA inspectors could not take samples or get access to the areas.

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)

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