China FDA to Begin Surprise Inspections in September

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 (DID, June 18). — Jonathon Shacat

$1,695 $1,395


Subscribe to Drug Industry Daily and save $300 off the regular one-year price of $1,695 — plus receive a FREE copy of our webinar CD, Understanding CDER's "Super" Office of Pharmaceutical Quality and Its Effect on You — a $287 Value!

Key Benefits

LINKS TO KEY DOCUMENTS — You get links to key documents that support DID's articles such as draft and final guidances, 483s and warning letters, proposed rules, closeout letter, full text of proposed legislation and GAO reports.

ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.