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FDA REGISTRATION
Global Brand provides consulting services and support for FDA certification to national and international production facilities. International FDA certification is a key requirement for manufacturing facilities to export food, drugs, API, medical devices and cosmetics to the US market. Global Brand will provide quality service at a reasonable cost and in a specific time frame.
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WHY SHOULD YOU CHOOSE GLOBAL BRAND?
WHY SHOULD BUSINESSES REGISTER FDA?
Step 1: Receive information and advice on FDA registration process
Receiving information about production facilities, owners and products.
Step 2: Facility registration
Registration of manufacturing facilities with the FDA and registration of sub-certificates for special goods in accordance with FDA regulations.
Step 3: Advice on packaging re-design according to FDA standards
(Applies to processed and consumer products) Customers will provide packaging samples designed with package sides in full details. Global Brand experts will advise and guide according to the FDA standards.
Step 4: Apply updated FDA safety standards to factory processes
Enterprises need to update the records and run the production process in accordance with the food safety standards of ATTP FSMA.
Step 5: Declare shipments coming into the US (Prior Notice)
Prior to shipping to the US, Global Brand will assist customers to declare Prior Notice applications at least 15 days in advance with the FDA. This application includes shipment information, import and export information and related information.
Step 6: Hand over the results
Hand over the documents related to the FDA certification process as soon as the business registration result is out.
Step 7: FDA inspects the factory after successful registration (only after receiving notice from FDA)
FDA will give 3-6 months prior notice of business inspections. The person in-charge of the business will exchange and provide information to the FDA regarding the business and manufacturing facilities, confirm the inspection date and prepare records as required by the FDA.
Q&A
Frequently asked questions
- Food
- Functional foods
- Dietary supplement products
- Prescription or non-prescription pharmaceuticals
- Vaccine
- Blood transfusion
- Medical equipment
- Equipment emitting electromagnetic radiation
- Products related to veterinary
- Cigarette
- Cosmetic
When shipping to the US, FDA is one of the most important papers. Goods such as dried shrimp, dried fish, cakes, candies, jams, drugs, tea etc. must apply for this certificate. Such goods have to undergo customs clearance to be imported into the United States.
All FDA-regulated items must comply with the organization’s strict rules if they wish to obtain FDA certification. Each FDA Certificate is granted for each product type only, without limitation of quantity or weight.
Yes. This is in the FDA regulation.
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