First on that list are obviously companies with a bad history, ie., previous violations, or recalls. Some industries require a routine overview for various legal reasons, or a company that has potentially harmful practices might be reported by a customer or employee or importer to the FDA In a variety of ways.
All of these seem perfectly reasonable, the kinds of company not complying with the law. How do the rest of us food and beverage manufacturers get picked ?
The FDA also uses “a tiered approach based on factors such as risk, volume of products, complexity of processes, etc.” It could be as simple as geographically convenient, because the inspector is going to your country anyways, though they try to inspect only one type of product at a time.
Based on the volume of imported products from specific areas, the FDA maintains permanent offices in China, India, Europe, Latin America, and Sub-Saharan Africa.
Failure to register your facility with the FDA is prohibited. If a foreign (food/beverage/medical device) facility is required to register with FDA, but fails to do so, that company runs the risk of having their exported products from their unregistered foreign facility seized by USA customs and destroyed before actually arriving in USA.
Seems like a big risk for a small registration that lasts 2 years.
New facilities, register now ! so you don’t have to file again until 2016. Already registered earlier this year (or last) ? You must do it again by December 31, 2014.