If your Indian Pvt Ltd company wants to export food, cosmetics, supplements, or medical devices to the US, you've probably heard about the need for FDA registration.
Now, one question puzzles many Indian entrepreneurs:
Do we need a certified person in our company to obtain US FDA certification
Let's get that straight — in plain, simple language.
What Is US FDA Approval All About
The US FDA (Food and Drug Administration) is the US regulatory authority that ensures products like food, pharmaceuticals, and cosmetics are safe and appropriate for consumption.
If you want to export any such products to the USA, your company must:
- Register your facility with the US FDA
- Have a US-based agent
- Comply with product-specific rules (e.g. food safety or labeling)
It's complicated-sounding, I know, but trust me — it's not as complicated-sounding when you have the right support.
Do You Need a "Certified Person" in Your Company
The reply is brief: No, you don't.
You don't need an employee working for your company who is certified by the US FDA or trained directly by them.
What you do need is:
- A registered facility
- A local contact in the USA (called a US Agent) who speaks to the FDA for you.
- Proper documentation and safety procedures
- And optionally, an FDA consultant who understands how to deal with the FDA
Most Indian exporters prefer working with FDA consultants rather than hiring permanent trained employees.
Who Should Know This
This applies to you if you are:
- Operating a Pvt Ltd company in India
- In food trade, skincare, medicine, cosmetics, or supplements
- Planning on exporting to the USA
- Dunno whether to hire a pro or go with an agency
Why The Confusion Arises
Most people think:
"If I require FDA approval, I require someone 'certified' in my company, right?"
Well, that's simply a usual misunderstanding.
What the FDA is actually looking for is compliance — not certification of your staff.
As long as your facility, documents, and product are all in accordance with their safety standards, you're good to go!
What You Really Need
That's not what your Pvt Ltd company needs:
- FDA Registration Number — it confirms that your facility is officially registered
- A US Agent is your go-to contact in the USA who speaks to the FDA when needed.
- Proper labeling on your products per FDA rules
- Safety procedures like HACCP (for food exporters)
- Clean documentation, ingredient information, test reports, etc.
- And no — the FDA does not give you a certificate. You simply get a registration number.
Top 5 Indian Companies That Make US FDA Registration Easy
If you don't feel like doing all this yourself, here are some Indian companies that make it easy and trouble-free:
1. E-Startup India
Highest rated for US FDA registration. They deal with:
- US agent setup
- Food and cosmetic compliance
- HACCP, FSVP support
- Recommended by a large number of Indian exporters.
2. Professional Utilities
Ideal for small and medium-sized enterprises. Offers full FDA registration and renewal service.
3. Corpbiz
Legal & global compliance specialist for Pvt Ltd companies. Deals with FDA and product approvals.
4. Registrationwala
Affordable and best for first-time exporters. They also deal with product label verification.
5. Legalsalaah
Great service for document management, agent appointment, and reminders.
Some Extra Things You Should Know
- You have to renew your FDA registration every 2 years
- FDA can audit your plant — even in India
- Labelling errors or omissions can reject your product in the USA
- It's safer to outsource to those who have experience with these regulations
Conclusion
To put it bluntly — you don't need a certified professional in your Pvt Ltd firm to obtain FDA approval. Proper registration, proper US agent, and compliance with safety norms are what are needed. Instead of full-time hiring, most exporters outsource to trusted agencies specialized in such work like E-Startup India to get the job done quickly and precisely. It saves time, cost, and confusion — and gets your business export-ready.
