China FDA to Start Surprise Inspections in Fall

The China Food and Drug Administration will begin conducting unannounced inspections of drugmakers in September.

The CFDA says companies can expect teams of investigators armed with cameras, photocopiers and recording devices to investigate reports of complaints and adverse events and check that firms are following good manufacturing practices. Drugmakers will receive a summary of the inspection results and have an opportunity to correct any problems.

Anyone alerting firms to a surprise inspection risks disciplinary action, including criminal prosecution, the agency warns.

China has also been stepping up oversight of overseas manufacturing sites. As of last month, the CFDA had conducted 30 foreign inspections this year — 11 more than in all of 2014. — Jonathon Shacat