On October 2, FDA announced on its blog a new data dashboard where users can view data regarding FDA inspections and enforcement. The dashboard currently contains data for fiscal year (FY) 2009 to FY 2013, and FDA plans to update the database twice a year. For now, the datasets only include final actions. Some of the data was previously available on the FDA website in downloadable spreadsheets, but in the dashboard, the information is presented as graphs.
When you enter the dashboard, you have two options for how to view the data:
Reports and Trends
The reports and trends section of the dashboard references more general statistics, such as the breakdown of FDA inspection conclusion reports. When FDA concludes an inspection it reports one of three things: Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI). OAI means an FDA inspection revealed significant objectionable conditions or practices and action must be taken to address the issues. VAI means FDA found objectionable conditions, but they did not warrant regulatory significance. NAI means FDA found no objectionable conditions that warrant further action.
In the dashboard, users can see how many of each type of inspection conclusions were reported by each FDA center. For example, in FY 2013, the Center for Food Safety and Applied Nutrition (CFSAN) reported significantly more NAI conclusions than OAI or VAI conclusions. The Center of Drug Evaluation and Research (CDER), however, reported nearly the same number of VAI conclusions as NAI conclusions.
Inspections by Country
You can also view data in the dashboard more specifically by country. You can see the number of inspections conducted in each country, and by clicking on a country, you can access more detailed information. You can see the number and types of inspection conclusions reported in each country and the number of inspections conducted by each FDA center in each country.
According to the dashboard, the United States has undergone the most FDA inspections in the past 5 years, with its count at an outstanding 81,971. Canada comes in second with 782 inspections, and China is a close third with 780. Keep in mind that there are significantly more U.S. facilities registered with FDA than other countries. Speaking of food facilities alone, over 80,000 U.S. food facilities are registered with FDA, while there are 6,433 Canadian food facilities registered with FDA.
It’s important to know that in 2011, the Food Safety Modernization Act (FSMA) directed FDA to increase the number of food facility inspections it conducts. FSMA mandated that FDA inspect all high risk U.S. facilities by 2016 and again every three years thereafter. FDA must inspect all non-high-risk U.S. facilities by 2018 and again every five years thereafter. For foreign facilities, FDA must double the number of inspections it conducts every year through 2016.
Along with mandating that FDA increase the number of inspections, FSMA granted FDA the authority to collect reinspection fees. Initial inspections cost nothing, but if the inspection reveals certain food safety issues and FDA decides to return, FDA will charge for every hour spent on the reinspection. This includes the time it takes FDA to prepare for the reinspection and to travel to and from the facility. The cost for reinspections in FY 2015 is $217 per hour for domestic facilities and $305 per hour for foreign facilities.
With the new financial risks associated with FDA inspections, it’s a good idea to prepare in advance. Registrar Corp offers a mock FDA inspection service for food facilities. We will send a food safety expert trained in FDA inspections to a facility to help prepare. If FDA sets a date for an inspection, this mock inspection service is offered free of charge to Registrar Corp’s U.S. Agent clients, other than travel and lodging expenses.
Registrar Corp is a consulting firm that helps companies comply with FDA regulations. Along with mock inspections, we offer registration services and label reviews to food, drug, device, and cosmetic companies. If you are interested in our services or have any questions regarding FDA regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Specialist 24 hours a day at https://www.registrarcorp.com/livehelp.
*Note: Similarly in August, FDA revealed a new API that gives users access to drug labeling and enforcement statistics.