Services to Ease FDA Regulatory Compliance

Requirements for selling food products in the USA

21

Jan

2019

Food Facility Registration

If you are a foreign company or importing food products manufactured in foreign country, then such foreign facilities are required to appoint U.S Agent and register the facility. Pragmatic Compliance LLC shall act as U.S Agent for food facility registration purpose and register the facility. Our fee for food facility registration including one-year U.S Agent services is $ 299

You can complete our online food facility registration form at the below link and make the payment. It will take less than two working days to obtain food facility registration number. We accept payment through Credit Card, PayPal or Wire transfer.

Food Facility Registration Form

If you are domestic food manufacturing, processing, packing or warehouse facility, you are required to register with FDA. Our fee for domestic food facility registration is $ 199. Please contact us for offline form.

If you are U.S importer or Trader then you are not required to register with FDA, however your manufacturer is required to register with FDA.

Please note, FDA does not issue the food facility certificate and certificate is not required. You will get the food facility registration number from FDA through email. Our company can issue the food facility registration certificate.

Labeling Compliance

Before shipping products to the USA, you should make sure your product labelling is as per FDA requirements. We can offer labelling review services and our fee for per product labelling review is $ 299. In order to review the label, you should provide us label design in PDF or image format. If you fail to proper labelling FDA may detain your products at the port of entry. Generally, it takes 4 working days to complete the labelling review.

We offer discount on multiple labeling review.

Prior Import notice
Before shipping goods, you must notify FDA about arrival of your shipments well in advance by submitting prior import notice.

If you wish to file prior import notice yourself, we can send you the step by step instruction which you can follow and submit the prior import notice. If you want us to submit prior import notice, then our fee for per shipment prior notice filing is $ 20. Your shipping companies /agents may offer prior import notice filing services free of charge, please check them.

FSVP Agent or Importer

Foreign manufacturer is required to identify the importer for FSMA compliance purpose. If you are importer or already have importer in the United States, such importer is responsible for supplier verification responsibilities.

Pragmatic compliance can act as FSVP importer for foreign companies, fee for FSVP Agent services depends on the Product and projected annual sales in terms of USD.

Foreign manufacturer has to go through our supplier evaluation process and we may require several product quality and safety related documents in order to act as FSVP Agent. Please contact us for more information.

Good Manufacturing Practice and HACCP

In order to food and dietary supplements in the United States companies should follow GMP and maintain proper documentation. After the facility is registered you can start shipping the products however FDA may visit your facility at time.

Note: – If you are low acid or canned food manufacturer please contact us for more information.

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