FDA Begins Unannounced Inspections in India

The FDA has begun a pilot program of unannounced inspections of drug manufacturing facilities in India, according to Judith McMeekin, FDA associate commissioner for regulatory affairs.

But the agency has not yet begun unannounced inspections in China, which were also anticipated as part of the pilot, she explained, during an April 6 webinar hosted by the Alliance for a Stronger FDA.

In the past, the agency has avoided unannounced foreign inspections because of logistical obstacles, such as unreliable transportation in remote areas and the need to be escorted while doing inspections in restricted economic zones.