The United States Food and Drug Administration (FDA) is expected to escalate the number of food facilities they inspect each year for the next five years as a result of the Food Safety Modernization Act (FSMA). FSMA specifically mandates the number of foreign food facilities the FDA is to inspect each year until 2016 (See U.S. FDA Food Facility Inspections). This substantial increase in food facility inspections means the likelihood your food facility will be inspected is far greater than in the past. In addition, FSMA food facility inspections enhance the likelihood your food facility will be re-inspected, resulting in costly fees. FSMA states the hourly rates at $325/hr for time spent outside the United States and $224/hr for associated activities performed in the United States relating to the re-inspection. Food manufacturers need to make sure they do everything they can to prepare to “pass” the first inspection and avoid expensive fees associated with a re-inspection.
To assist our clients in preparing for an initial FDA inspection, Registrar Corp is pleased to offer a “Pre-Inspection Audit Service.” Registrar Corp’s knowledgeable team of multi-lingual experts, some of whom have worked for or received training from FDA, will help your company prepare for an initial inspection. This service is available for clients who receive a notice of inspection dated October 1, 2012 or later. October 1, 2012, is the first day a firm is required to re-register with FDA under the Food Safety Modernization Act.
For questions related to U.S. FDA Foreign Food Facility inspections or any U.S. FDA regulation, please contact Registrar Corp 24/7 at www.registrarcorp.com/livehelp or call us at +1-757-224-0177.