The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / GMPs / Inspections and Audits

FDA to Slash U.S. GMP Inspections by 40 Percent

March 14, 2014

The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in favor of conducting more inspections overseas. The shift is part of a broader agency push to improve the quality of drugs imported into the U.S.

The change also brings the FDA closer to achieving its longtime goal of bringing parity to U.S. and foreign inspections, so that foreign drug manufacturers would be as likely to be inspected as U.S.-based facilities.

The FDA plans to conduct 591 domestic good manufacturing practice (GMP) inspections in fiscal 2014 and 2015, down from the 967 performed last year. The agency in turn hopes to perform 30 percent more foreign GMP inspections, conducting 843 inspections each year, up from last year’s 604.

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 new estimates were released in an HHS memorandum supporting the White House’s proposed fiscal 2015 FDA budget.

The push for more foreign inspections is the latest wrinkle in the agency’s oversight of manufacturing quality. It recently announced plans to create a pharma-only enforcement unit that will provide more consistent inspections and enforcement decisions. The reorganization would result in specialized teams of investigators.

And the agency is at work developing a set of product and site quality metrics it wants to use to refine its processes for determining if an inspection is necessary.

The new projections on foreign inspections also reflect the agency’s recent placement of investigators in India and China, which produce a majority of finished drug products and active pharmaceutical ingredients imported into the U.S.

Just because the FDA is cutting the number of domestic GMP inspections doesn’t mean that you can fly under the radar. Medical Device Quality & Compliance Institute 2014 will help you and your colleagues stay in touch with the latest standards, so reserve your place today.