FDA decreases domestic GMP inspections

The FDA plans to decrease its routine quality or GMP inspections in the U.S. by 40% and thereby increasing overseas inspections. This shift shall improve the quality of drugs imported in the U.S. and also bring the FDA closer to achieving its longtime goal of bringing parity to domestic and foreign inspections.

The FDA plans to conduct 591 domestic GMP inspections in fiscal 2014 and 2015 which are less than 967 inspections conducted last year. And in turn hopes to increase 30 percent of foreign GMP inspections that is 843 inspections in a year which were 604 last year. The companies will be chosen for inspection based on the agency’s risk-based inspection model that grants leeway to high-quality companies. The FDA takes into account risk factors including Class I recalls and adverse events, as well as compliance history, in applying the risk-based inspections model to its decision making.

The manufacturing facilities in India and China will be examined closely and with more attention than in the past. Recently, FDA has issued an import alert for two Chinese manufacturers. And in some Indian companies also the FDA has continually identified significant lapses in quality.