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