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US FDA Certificate
The US FDA Certificate generally means that companies registered with the US Food and Drug Administration are often asked by their customers and suppliers to verify their FDA registration number and validity date, especially in the case of food manufacturers and exporters.
Manufacturers, Exporters, and Traders across the globe are curious to have the word “FDA Certified” in the name of the company. But this is not possible! The US FDA will not issue any kind of certificate to any organization other than domestic manufacturing companies.
Are you looking for FDA certification for your medical devices, food, drugs, or cosmetics? Our expert team is here to assist you through the registration and listing process, ensuring your products meet all FDA requirements.
US FDA Agent and FDA Certificate
Domestic firms exporting products from the United States are often asked by their foreign customers or foreign governments to supply a “US FDA Certificate” for products regulated by the food and Drug Administration. An FDA Certificate is a document prepared by the U.S. Food and Drug Administration, containing information about a product’s regulatory or marketing status.
- We are US FDA Agents and regulatory consultants having offices in the USA, UK, Germany, and India.
- We provide a certificate that acts as a third-party verification of your registration status.
- Third-party certificates will not possess legal validity, and the US FDA does not acknowledge these issued certificates of registration.
- To obtain a certificate, please write to us or fill out the quick contact form on the left side.
FDA Food Facility Registration
FDA Food Label Review
US FDA Certificate Validity
US FDA Certificate issued by US Agent is valid for 1 year from the date of issue. The validity of the certificate can be increased based on request and payment. FDA food facility registration is confidential. FDA never discloses registrant information to the public. Due to this reason, your potential buyer from the USA can ask for additional information such as login details or FDA Agent issued US FDA Certificate.
Our US FDA Certification fees start at 350 USD depending upon the product and type. We will organize the certificate in six hours’ time on working days.
FDA Certificate Vs FDA Approval
FDA certification generally refers to formal documentation issued by the FDA or any third party that certifies compliance with specific standards or regulations. whereas FDA approval is a formal document after a rigorous process to evaluate the safety, efficacy, and quality of drugs, biologics, and high-risk medical devices.
Across the globe, many manufacturers use the word “FDA Approved” on their primary labels, secondary packages, and websites. This is NOT correct! It is added only for commercial promotions. The U.S. Food and Drug Administration never accepts the statement.
- FDA doesn’t approve manufacturers of any kind of activity.
- FDA approves new medical devices and certain high-risk medical devices.
- FDA doesn’t approve Food, Cosmetics, OTC Drugs, and Compound drugs. FDA approves new drugs and biologicals before companies can market those items.
Frequently Asked Questions
What is FDA Color Certificate?
All colour additives, except coal tar hair dyes, need prior FDA Approval before being used in food, drugs, or cosmetics. The FDA Color Certificate is for the batches of colour manufactured to use in/on humans and animals. It is issued after thorough analysis at designated facilities by the FDA. FDA issues colour certificates based on the test result.
Can I advertise my facility is FDA Certified?
FDA will NOT issue any certificate, so you cannot say your facility is FDA Certified.
How much does it cost to get FDA approval?
The cost of FDA Approval depending on the products. Contact us for more details.
What is the validity of US FDA Certificate?
The FDA certificate issued by a US FDA Agent is valid for 1 year from the date of the initial issue.
To obtain a US FDA Certificate?
The US FDA will not issue any certificate. We FDA Agents issue certificates soon after the facility or establishment registration with the FDA using our US Agent Service.
What is an FDA Certificate?
An FDA Certificate is issued to domestic manufacturers by the Food and Drug Administration for the smooth acceptance of US products in other countries.