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US FDA Certificate

 

At RAPS, we assist businesses in navigating the complexities of US FDA registration and compliance.

The term "US FDA Certificate" typically refers to documentation verifying that a company is registered with the United States Food and Drug Administration (FDA). Customers and suppliers, especially in the food industry, frequently request proof of FDA registration—such as the FDA Registration Number and its validity date—to ensure that a manufacturer or exporter complies with US regulations.

 

However, it is important to understand that the FDA does not issue official certificates to organizations, except for certain domestic manufacturing facilities. Despite the widespread desire among manufacturers, exporters, and traders worldwide to label their company as “FDA Certified,” this term is often misused and misunderstood.

Instead, companies may obtain a Certificate of FDA Registration through authorized third-party agents, which serves as evidence of registration but is not an endorsement or certification by the FDA.

At RAPS, we provide comprehensive support in registering your company with the FDA and supplying you with all necessary documentation to help demonstrate compliance to your clients and partners.

 

US FDA Certificate for Export

When exporting products from the United States, domestic manufacturers are often required by foreign customers or international regulatory authorities to provide a “US FDA Certificate” for products regulated by the U.S. Food and Drug Administration (FDA).

This certificate, when issued by the FDA, includes details about a product’s regulatory or marketing status and is typically required to facilitate smooth customs clearance and compliance in the destination country.

At RAPS, we serve as FDA U.S. Agents and regulatory consultants with offices in the USA, UK, Germany, and India. While the FDA itself only issues specific certificates for certain products and purposes, we offer a Certificate of FDA Registration as a third-party document that confirms your registration status with the FDA.

Please note:

  • This third-party certificate does not hold legal validity and is not officially recognized or endorsed by the FDA.
     
  • It is, however, widely used for business and documentation purposes to demonstrate compliance and registration.
     

To request your certificate, simply contact us or fill out the quick inquiry form on the left-hand side of this page. Our team will get back to you promptly with the necessary steps.

 

Validity of US FDA Certificate

The US FDA Certificate issued by a US FDA Agent—such as RAPS—is typically valid for one year from the date of issuance. This certificate serves as a third-party confirmation of your FDA registration status.

If required, the validity of the certificate can be extended upon request and additional payment.

Please note that FDA food facility registration details are confidential. The U.S. FDA does not publicly disclose registrant information, which is why U.S. buyers or business partners may request:

  • A copy of your FDA registration certificate issued by your agent
     
  • Login credentials to verify registration (if applicable)
     

At RAPS, we ensure that your registration documents are professionally issued and meet industry expectations, helping you build trust with your partners and clients.



 

US FDA Certificate vs. FDA Approval

There is often confusion between FDA Certification and FDA Approval, but the two are very different.

A US FDA Certificate typically refers to documentation issued either by the FDA (in limited cases) or a third-party FDA Agent, verifying that a company or facility is registered with the FDA and complies with relevant regulatory requirements. This is commonly used for industries such as food, cosmetics, dietary supplements, and low-risk medical devices.

On the other hand, FDA Approval is a formal and rigorous process carried out only for specific product categories—such as:

  • New drugs
     
  • Biological products
     
  • Certain high-risk medical devices
     

This process involves extensive evaluation of safety, efficacy, and quality before these products can be marketed in the United States.

⚠️ Important Note:
Many manufacturers around the world mistakenly use the phrase “FDA Approved” on labels, packaging, and websites for products that have not undergone FDA’s formal approval process. This is misleading and not accepted by the FDA.
 

What the FDA Does Not Approve:

  • Food products
     
  • Cosmetics
     
  • Dietary supplements
     
  • Over-the-counter (OTC) drugs
     
  • Compounded drugs
     
  • Manufacturers or facilities
     

At RAPS, we help you stay compliant by clarifying these distinctions and guiding you through the correct certification and registration processes.

 

Ready to Comply with Confidence?

At RAPS, we simplify your path to US FDA compliance by providing expert guidance, trusted FDA agent services, and clear documentation support. Whether you're registering your facility, exporting products, or demonstrating compliance to partners, we ensure your FDA-related needs are handled with accuracy and integrity.

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