FDA Trying to Increase Placement of Auditors in China

FDA Trying to Increase Placement of Auditors in China

November 6th, 2013 // 3:26 pm @

FDA has reported this week that getting visas approved for new FDA inspectors in China is taking longer than they hoped. The idea was for FDA to double its presence in that country.

The delays are continuing as FDA has only eight auditors based in China. It asked the government there in 2012 about being able to add up to 20 more inspectors.

FDA is continuing to work with the US State Department and the Ministry of Foreign Affairs in China to get the visas issued. The Ministry is doing a review of FDA’s plans , but no timetable has been released on a when a decision will be made.

FDA spokesperson Stephen King reported to In-Pharmatechnologist.com that FDA is still optimistic that China will let in the new auditors. The spokesman for FDA said that the agency thinks the US and Chinese governments will come to an agreement soon.

There has been a call for more FDA inspectors in China for years, and there has been a US budget increase of $10 million to increase FDA’s capacity in China. The budget calls for 16 more inspectors in China.

FDA is for now just sending in auditors who can make short trips to do audits. These inspectors are not allowed to stay in the country for a long period.

India also has been having issues getting auditors into China to look for cGMP violations. The drug industry in India gets 90% of its raw drug materials from China but does not have any inspection facilities there yet, according to In-Pharmatechnologist.com.


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