Changes imposed by the U.S. Food Safety Modernization Act (FSMA) are starting to take effect. For the first time, the United States Food and Drug Administration (FDA) exercised its new power to suspend a food facility registration. On November 26, 2012, Sunland, Inc. (a New Mexico, USA food facility) was ordered to shut down operations immediately. The company may not resume manufacturing, processing, packing or holding food unless and until permitted by FDA.
This episode is likely just the start of FDA exercising its new powers. Prior to FSMA, overseas food facility inspections were rare. FSMA requires FDA to inspect at least 37,200 food facilities by 2016, and 19,200 annually after that. Most food facilities in and outside the U.S. will be inspected by FDA eventually. And FDA has now shown that it may exercise its new power to suspend food facility registrations, thereby barring those food facilities from the U.S. market.
Registrar Corp clients may be able to breathe somewhat easier about this situation than many other companies outside the United States. As part of its U.S. Agent service, Registrar Corp will dispatch a food safety expert familiar with FDA inspections to help the company prepare, so that the company knows what to expect when FDA arrives. If the inspection goes well, there should be no fear that FDA may wield its new power to suspend the inspected facility’s registration.
No other U.S. Agent offers such pre-inspection assistance. This assistance is included as part of Registrar Corp’s U.S. Agent service at no additional charge other than travel and lodging expenses.