Foreign Facility Certification (FCE) – If your business operates outside of the United States and intends to export FDA-regulated products to the U.S., FCE filing is a crucial step. This certification demonstrates that your facility complies with FDA regulations and is eligible to export to the U.S.
Substance Inventory Database (SID) – For manufacturers of food and food-related products, SID filing is essential. It involves listing the substances used in your products to ensure their safety for consumers. Accurate SID information is vital for compliance with FDA regulations.