What is the concept of FDA certification?
The FDA (Food and Drug Administration) is the United States Food and Drug Administration, which operates under the U.S. Department of Health and Human Services. The FDA standard was established in 1906, with its headquarters in White Oak, Maryland, and is responsible for protecting and promoting public health through the regulation and supervision of food safety.
The FDA has 223 offices and 13 laboratories across the U.S. states. As of 2016, the FDA has established offices in several countries around the world, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
The U.S. market requires that businesses obtain FDA certification if they wish to export goods to this market. For every type of product you want to export, you must apply for a separate FDA certificate. Each FDA certificate is valid for only one type of product and cannot be combined for multiple food items. However, there are no restrictions on quantity or weight.
The role of FDA certification
FDA certification plays a crucial role in the procedures for exporting goods. The FDA certificate serves as a “passport” for your products. Any product intended for export must go through the FDA certification process and be subject to strict food safety inspections. Without an FDA certificate, goods will not be allowed to clear customs, meaning the shipment will be returned or immediately destroyed at the border.
For imported goods entering the U.S. market, if violations occur, all goods will be held at the port under the supervision of the FDA and CBP (Bureau of Customs and Border Protection). This case will be handled under Section 801(m)(1) and Federal regulations. You will be responsible for all costs incurred for storage, removal, and disposal of such goods.
Under Federal law, the U.S. government may prosecute businesses or individuals who violate this Act.
Procedures for obtaining FDA certification
Below is the process and procedure for applying for FDA certification at Onesource Solution. First, you need to prepare a dossier including the following documents:
Application for certification
Business registration certificate
Company information (address, scale, products, etc.)
HACCP/ISO 22000 certificate (if available)
Contact information of a U.S. representative office
Information of the person responsible for FDA matters
Other information (depending on the case)
7 Steps to register for FDA certification
Step 1: Onesource Solution and its partners will provide free consultation for your business on matters related to FDA license registration.
Step 2: Guide you in filling out all FDA registration information.
Step 3: After receiving complete information, Onesource Solution will create an account for your business in the FDA system.
Step 4: Onesource Solution will log in to the FDA system, register the account, and declare the product details.
Step 5: After the payment is received, the FDA system will automatically update the PIN and PCN codes to the account registered in your business’s FDA registration system.
Step 6: Once the PIN and PCN codes are obtained, Onesource Solution will enter them into the FDA system, submit the application, and issue a temporary FDA number for your business.
Step 7: Deliver the authenticated temporary FDA certificate to your business.
