The FDA carries out inspections and investigations whose purpose is to assure that international standards for food, drugs, biologics, and medical devices intended for import into the USA meet the requirements of the FMSA signed into law in 2011. 

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.

 


Comments

06/28/2015 2:20am

That is an interesting way to determine which facilities to inspect!

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02/02/2016 8:07pm

It could be as simple as geographically convenient, because the inspector is going to your country anyways.

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04/23/2016 5:25am

Facilities of the different institutes and affairs of the life rave very important and significant. It is amazing and tendency of the right and exact us. It is introduced wish the bright and right element of the life and all such elements. It is tersely done and enhanced.

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07/08/2016 12:26am

What industries are requiring a routine overview for various legal reasons?

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01/29/2017 5:21am

Satisfy the mystery here is basic. Many agents experience the ill effects of Lender Phobia. They are actually reluctant to address the "Checkwriter". Help yourself out and call a few loan specialists and meeting them. Banks hope to be called by experts. They profit when you bring them great advances. They need your business.

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04/05/2017 7:27am

Just make sure that they done everything right. We need an inspection here.

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