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.

 
 
The globalization of the last century has resulted in a myriad of imported goods that Americans want or need.   The USFDA (US Food & Drug Administration) has been around in early form since 1848, modernized in 1906, and given its current name in 1930.  The mandate changes with the signing of every new law.

The FSMA (Food Safety Modernization Act), signed into law in early 2011, is the most sweeping reform of US food safety laws in more than 70 years because its goal is to shift the focus from responding to food contamination to preventing it instead. 

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. 

The FSMA registration requirements apply to domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption.  Food facilities required to register with FDA must renew their registrations with FDA every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year, regardless of when the initial filing was made. 

The failure to register your facility is a prohibited act.  If a foreign food facility is required to register with FDA, but fails to do so, exported product from that facility into the U.S. is subject to refusal.  It could be seized by customs and destroyed without ever leaving port of entry in USA.  It certainly will not be returned to you.

Seems like a potentially big loss for a small registration filing that last 2 years.

New companies, file now !  then you don’t have to file again until 2016.  Existing facilities even if you registered earlier this year (or last) you must file this renewal in 4th Q 2014.

 
 
YES you do need this registration if you want to do business in USA.

It’s been a long time in coming, but after nearly 10 years, there is a new requirement by the FDA, that any facility within or without the USA, that deals with products for human and/or pets must file with the FDA every 2nd year, starting in 2012…SO YOU MUST FILE AGAIN IN 4th Quarter 2014….no matter when you filed last.

The Bioterrorism Act was enacted December 2003 and directs the FDA to take steps to protect the public from a terrorist attack on the US’s supplies.

Nearly 10 years later, the FSMA became the law that provides the actual infrastructure under which the FDA can implement and enforce the Bioterrorism Act.

Specifically, if FDA determines that products manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences to humans or our pets, FDA may suspend the registration of your facility which could effect your imports into USA.

WHICH FACILITIES MUST FILE WITH THE FDA ?

Owners, operators, and agents in charge of any facility that deals with certain products used by humans and/or pets.

Any facility which:

  • manufactures
  • processes
  • packs
  • holds (such as your distributor’s or customs brokers’ warehouse)
WHAT PRODUCTS MUST FILE WITH THE USFDA ?

Anything for human or animal use, such as:

  • beverages
  • food
  • wine & spirits
  • cosmetics
  • pet products
The law covers any product, whether ingested, or for use inside or outside the body of a human or a pet. The law pertains to both USA and imported products and facilities that handle products to be available in USA.