Exporting Your Products to the United States
| Each year, more than 12 million products processed in Steriflow autoclaves are exported or produced in the USA. Since 1979, 520 Steriflow in the world have been accepted by FDA for processing of products exported to the USA With our Steriflow your FDA agreement is guaranteed! |
The United States Food & Drug Administration (US FDA) is responsible for the regulation of all US human and animal food products except for meat and poultry.
In order to export products to the United States, the followings are required:
1.) All foreign facilities that manufacture, pack, process or hold food for human or animal consumption in the United States must register their facilities with FDA. All foreign entities must also have a designated US agent. This can be an importer or a consultant. The enclosed link has more information:
http://www.fda.gov/oc/bioterrorism/bioact.html
2.) All processors of low acid and acidified foods must register their facilities with FDA and receive a FCE (Food Cannery Establishment) number. For information on what items qualify and how to do this, see the enclosed link: http://www.cfsan.fda.gov/~comm/lacf-s1.html.
Forms for FCE are available on the following web page under Food Canning Establishment Registration FDA Forms 2541a: http://www.cfsan.fda.gov/~comm/lacf-toc.html.
3.) All processors of low acid and acidified foods must register their processes with FDA and have their processes accepted to allow entry into the United States. This is done by filling out Process Food Canning Establishment Filing Forms. 2541c forms are available on the following web page http://www.cfsan.fda.gov/~comm/lacf-toc.html.
4.) In addition to process filing forms, processors must submit a temperature distribution study.
The acceptance time for process filing forms is typically 3-5 months.
In order to ensure that validation is done per FDA requirements, Steriflow has a long partnership with PhF Specialists Inc., San Jose CA USA, a FDA recognized process authority. The on site validation of Steriflow systems or temperature studies can be done either by STERIFLOW SAS or by Phf. Information about PhF is available at www.phfspec.com. PhF can also serve as an agent for food facility registration.
