FDA plans significant increase of GMP Inspections in China

For quite some time, the US FDA has elaborated concrete plans to increase the number of inspections in China. These plans were developed as a

consequence of the Heparin crisis. Already in 2008, the US FDA opened offices in China to increase the number of GMP Inspections. However, little progress has been made since that time.

In parallel, the US FDA has identified some major problems with pharmaceutical and API manufacturers in India. A number of Warning Letters addressed to Indian companies have been published. More seriously, the inspections findings which caused the Warning Letters did not only contain GMP deviations but also cases of fraud and falsification of data.

There are concerns that a lack of supervision might have caused similar non-compliance situations in China as well. Yet, without a comprehensive inspection programme in place there is no proven evidence for such a concern. The website

Pharmalot has just recently reported about the problems which caused the delay in performing more inspections: China has refused to issue visa for FDA staff. This issue has now been solved.

The

US White House has published a statement on December 5th about a new agreement with China. According to a new Pharmalot article, the US FDA will now increase its inspection activities.