Business

FDA registration does not have to be a difficult process for people to go through but a decision may have to be made. You may have to decide if you would rather spend a significant amount of your time hunting down various kinds of information or pay someone else to handle this task for you. Businesses outsource all kinds of activities in todays world and taking care of FDA registration is one of the areas that people can outsource.

Sometimes companies look at the costs that may be involved in hiring some help and feel they may not want to invest their money in this way. One thing to consider is how much is your time or a particular employees time worth, especially if they have to put in 20 to 30 hours in the initial stage of FDA registration. If this individual has to be pulled from another project, the value of the time may increase significantly, making bringing in some help very attractive.

Getting Help with FDA Registration
There are a number of people who are qualified to help companies through the registration process and can get results in very short amounts of time. One of the reasons for this is because it is an area that these people specialize in and so they know how to do it quite well. People who are experts in a certain area can usually perform tasks faster and more accurately than people who are complete novices in the same area.

Because a US agent has experience with FDA registration, they can usually complete this process for their clients somewhere in the neighborhood of 1-3 hours. This can be a great time saver especially if the person you would assign the task to has to spread the work out over several weeks before they can get it done. With some registrations, the faster they can be taken care of the better.

An FDA registration number must be obtained by every single foreign owner, operator or company that wants to supply food for consumption to the United States of America. This is a relatively new change in FDA guidelines and went into effect in October of 2003. For companies that were already supplying food to the USA, a deadline was set to register by December 13, 2003.

It does not matter if the food that will be supplied is for dogs or people; every foreign facility that the food spends time in has to be registered with the Food and Drug Administration. An FDA registration number must be obtained for each separate facility that the company may use to store, package, process or produce food for consumption. Companies that have not registered can still go through the process of registration but need to do so before any food is made available to the USA.

How to Obtain an FDA Registration Number of Foreign Facilities
Foreign companies are required by law to work with a US agent in the USA who has been approved to submit applications for an FDA registration number for each facility of the company they represent. This US agent may be different from the import/export agent or customs agent that is currently used. The US agent represents the foreign entity to the FDA.

The US agent will fill out all of the paperwork necessary to register the company to supply food to the USA. The amount of time it takes to complete the process varies from one situation to the next. For the most part, it can be done within a day or two.

FDA regulatory compliance is necessary for every business that provides products under the watchful eye of the Food and Drug Administration. For almost a century, the FDA has been used by the federal government to make sure companies are providing products that are safe for people to use. It takes an amazing group of people who perform all kinds of different duties to make life as safe as possible for the citizens of the United States of America.

The FDA has over 9,000 different employees that form a huge team that makes sure all of the guidelines under the control of this government agency are followed. There are office workers, administrators, inspectors, biologists, micro-biologists, engineers and many other highly skilled people who work for the FDA. Each year, these people are responsible for providing over 16,000 facility inspections.

Meet FDA Regulatory Compliance or Else
One of the things people need to realize is that FDA regulatory compliance is not an option, it is mandatory. If people break the law, they may get away with it for a little while but eventually they will get caught and it will not be a pretty sight to behold. This can be particularly true when dealing with issues that have to do with FDA regulatory compliance.

The problem is that one fault could cause a background search that brings up a number of other discrepancies in the company upon further inspection. This can cost a company a lot of money should they lose a civil suit that may happen. Even worse is the possibility of criminal charges being filed and guilty verdicts delivered.

Food facility registration has become a way of life for any company that wishes to make food available for people and animals to eat in the United States of America. The Bioterrorism Act of 2002 that was actually put into effect in 2003 made this change in the law. Any company that packages food, stores food, processes food or manufactures food for the USA must register with the Food and Drug Administration first.

The FDA regulates a number of different areas as they relate to all consumable foods, medicines and some medical equipment as well as equipment that emits small amounts of radiation. All of this is done in an attempt to make all of these areas as safe as possible for the citizens of the USA. Without these regulations in effect, there is no telling how much damage people would have suffered over the last few decades.

The purpose of food facility registration is to create a paper trail for food as it passes from one facility to another and eventually arrives on someones plate. Each facility the food spends time in must be registered with the FDA even if they are all owned by the same company. This means one company may have to register a number of different facilities.

The Cost of Food Facility Registration
The cost of food facility registration with the FDA is free. Hidden costs primarily include the amount of time needed to get each of the facilities registered. Some turn this into a cost that is paid out to a US agent with the FDA who can get the registrations done in record time for a number of different facilities for a fee. Foreign facilities are required to use the services of a US agent to register and do business in the USA.

Foreign company registration varies slightly from the domestic registration in the United States of America. On the whole, domestic companies have things easier when it comes to registering with the Food and Drug Administration. One of the reasons for this may be that acts of terrorism are thought to be more likely to come from foreign interests but domestic food meant for general consumption is well regulated.

Aspects of Foreign Company Registration
One of the first noticeable differences between foreign company registration and domestic is that there are no exceptions for foreign facilities that have to register with the FDA. Every foreign company wanting to make food available to the USA must first register with the FDA and receive a valid registration number. This may be because the exceptions that apply domestically simply would not work for foreign companies.

Foreign companies are required to use the services of a US agent to file the appropriate forms for foreign entities. In the past many of these companies worked with a customs agent or an import/export agent but unless they are a US agent, they can not be used to file the all important form 3537. Unlike the domestic entities, foreign facilities can not use the US agent on a temporary basis.

The US agent used for foreign company registration is the same agent the company will need to use for however long they agree to work together. Any changes that take place with the foreign company as far as the FDA is concerned must be done in the USA by the US agent representing the company. The agent can handle a number of different duties on behalf of the company.