cGMPs / Compliance Management

FDA's Hamburg Travels to China, Pushes to Increase U.S. Inspectors

Source: Bloomberg

Nov 18, 2014

FDA Commissioner Margaret Hamburg will be in China this week to complete agreements on inspection and regulatory reviews, which will include pushing Chinese officials to grant visas for U.S. inspectors.

The FDA wants to increase the number of U.S. inspectors in China from eight to 26, but despite a commitment from the Chinese government last year, the visas haven’t materialized.

The FDA China office, opened in November 2008, is looking to bring on ten new hires to inspect drug manufacturing plants, seven to inspect food plants, and one in a management position.

Read the Bloomberg press release