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.