Did you know the U.S. exports more than 20% of its food? This makes it a lucrative market for Indian businesses!
To export food, drugs, cosmetics, medical devices, or PPE kits to the U.S., obtaining US FDA certification is essential. This certification ensures your products meet safety standards, protecting public health.
The US FDA, established in 1906, plays a key role in regulating biologically derived products. Securing FDA certification is both a mandatory step and a valuable asset for businesses looking to expand into the U.S. market.
So, how can you apply for the US FDA certificate in India? We’ll take a look at that, but first, let’s see how this certificate will help you establish your business in the USA.
Role of FDA Certificate
This certificate ensures that products like foods, drugs, medications, clinical instruments, natural goods, and beauty care products which emit radiation are safe enough for consumption by citizens.
- The US FDA requires registration for all packaging and repackaging of items imported into the U.S.
- It ensures the safety of the nation’s food supply.
- It maintains the standards and quality of food and drugs.
- It regulates rules for goods needing approval for U.S. export.
- It ensures products are regularly updated to meet health standards.
But to get the certificate, you need to file an application showcasing important documents. Come, let’s look at the documents that you would need.
Documents Required for FDA Registration
Here are the important documents:
- Landing bill
- Invoice issued from the entity
- Airway bill
- Details of purchase order
- Packing list details
- Labelling copies details
- Growers list details
- Proof showing the product’s real owner
- Details showcasing the export of products
- Other necessary documents
Now that you have all the documents ready, let’s see the process you would have to go through to get your US FDA certificate in India.
Process to Obtain the FDA Certificate
Follow the steps below for US FDA registration in India:
- Fill out the Form and Upload the Documents:
You are required to fill out the form on an online forum and enter all the essential details regarding the entity. You must mention details of the business, products, its owner, registration, its US agent details and more.
After providing the details and validating them, you need to upload the documents as proof of the form.
- Inspection:
Once you fill out the form and upload all the documents, an authority in charge will review and inspect it. The officials are also required to inspect the food and drug samples or products that you bring to the U.S.
Onto the next step.
- Issuing Form 483:
Once the inspection is complete, the officials issue Form 483 to the manufacturers. If they find any deviations during inspection, the form has a record of it.
The official must send a response to the FDA officials within 15 days, explaining the reason for any inspection deficiencies. It must also include a new action plan to address these shortcomings.
- Issuing EIR Report:
For you to get the FDA license, the officials may issue an Establishment Inspection Report. It specifies if there’s any action required on behalf of the entity. Such actions are usually pre-clinical testing or investigating new appliances.
- Warning Letter (May/May Not Happen):
If the FDA is unsatisfied with the response to Form 483, a warning letter may be issued. The manufacturer must reply within 15 days, ensuring the response addresses concerns to secure a U.S. FDA approved certificate.
- Approval or Cancellation Certificate Issued:
The U.S. FDA issues certification if satisfied with the inspection or response. However, unsatisfactory replies or inspections may lead to a warning letter or cancellation of the US FDA certificate in India.
Conclusion
Securing a US FDA certificate in India, if you want to export your products to the US. The process of doing so might be complex. But you can get the certificate right here in India. With expert guidance on registration and beyond, contact E-StartUp India for a smooth application and successful certification.
