FDA REGISTRATIONS AND COMPLIANCE

Registering with

The US Food and Drug Administration (USFDA) is a registration process specifically for factories that produce products for export. It does not involve product or goods inspections. At Terrasterial, we can only register products in the categories of dried fruits/vegetables, herbs, and products that do not contain animal ingredients.

USFDA Number

Once registered, you will receive a USFDA number. In the case of OEM (Original Equipment Manufacturer), it is necessary to obtain permission from the manufacturing factory before registering. You can use the product storage address, such as the packaging location, as long as the factory has previously registered.

Registering with the US Food and Drug Administration (USFDA) is necessary to be done through authorized agents. Importantly, the company seeking registration must be a legally established entity in Thailand.

At Pankesum, we are experts who provide consultation and handle the registration process. We can act as representatives and coordinate with agencies in the United States. These agencies have the authority to conduct random inspections of products imported into the US. Therefore, there may be associated costs that we are not responsible for. Registering with the USFDA is merely a notification and request for a registered number. It is similar to a Thai FDA number in Thailand.

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However, there is no issuance of certification documents from the FDA. The registration confirmation received by the registrant is simply a registered number.

Contact us for more information

Email: sales@pankesum.com