FDA Food Facility Registration for Suppliers in India

Between January 2021 and August 2026, FDA refused 145 lines of Indian food at the border on two charges that have nothing to do with contamination. "NEEDS FCE" means the maker wasn't registered as a low-acid canned or acidified food plant, and "NO PROCESS" means it hadn't filed the scheduled process for that product (our count of FDA's import refusal data). The goods were sauces, chutneys, condiments, mixed vegetables in sauce, cucumbers, mango products and chocolate-flavoured milk drinks. A plant can be fully registered with FDA as a food facility and still get every one of those refused, because facility registration is only the first of several US filings.

There's a second trap that catches small Indian exporters and their buyers. Companies sell "FDA registration certificates", with an FDA logo, to plants that think they need one. FDA says plainly that food facilities don't need a certificate of registration, that it doesn't recognise one issued by a private business, and that its logo isn't for private use (FDA (opens in a new tab)). This guide sorts the real filings from the paper. Importers first, then the steps for an Indian exporter. Other certificate guides are on certifications.

1. What Registration Is and Who Needs It

Under section 415 of the US Food, Drug and Cosmetic Act, any facility that manufactures, processes, packs or holds food for consumption in the US must register with FDA before it starts. Foreign plants are included. "Food" covers human and animal food, ingredients, dietary supplements and beverages.

There's one rule that matters a lot for Indian supply chains. If a foreign plant sends food to another foreign plant for further processing or packing before export, only the second one must register for that food. But if the second plant does something minimal, like putting on a label, both must register. Any packer or holder after the last processor must register too (FDA guidance, 7th edition (opens in a new tab)). So a merchant exporter that relabels in its own warehouse in Mumbai is in scope, and so is the plant that made the goods.

Registration gives the facility a number. FDA's own guidance puts it plainly - the number means only that the facility is registered, and it doesn't convey FDA approval or endorsement of the facility or its products.

2. What It Does Not Do

Registration is not an inspection result, a product approval or a safety check. It doesn't tell you whether the plant is on an import alert (read FDA import alerts for that), whether its lots pass residue tests (food import testing), or whether its labels meet US rules.

It also doesn't replace the other filings. Here is how they fit together.

3. What a US Importer Should Check

The number exists and is current. FDA keeps registrations confidential, so you can't look a plant up in a public database. FDA tells importers to ask the firm directly (FDA, importing human foods (opens in a new tab)). Ask for the registration number, the date of the last renewal and the name of the US agent.

Renewed in the current window. Every registration must be renewed between 1 October and 31 December of each even-numbered year. The 2026 window runs to 11:59 PM on 31 December 2026, and FDA treats any registration not renewed by then as expired and removes it from the account (FDA user guide (opens in a new tab)). If your supplier last renewed in 2024, it must renew again before the year ends.

The right plant. The address on the registration should be the plant that makes your product, and the last plant to touch it. FDA checks each registration's DUNS number against the facility address, so ask for the DUNS number too and see that the D&B record matches.

The US agent is real. Every foreign facility must name a US agent who lives or works in the US. FDA emails the agent to confirm they agreed to serve and won't confirm the registration until they do. Ask who it is. If the supplier doesn't know, that's a warning.

FCE and SID where needed. For pickles, chutneys, sauces, canned vegetables and shelf-stable milk drinks, ask for the FCE number and the SID for each product. FDA checks the SID at entry, and without it the product will be refused.

Red flags - a "certificate" with an FDA logo, an expiry date that isn't 31 December of an even-numbered year, a registration number that the supplier won't share, and a seller who says the FDA "approved" its factory.

4. What to Put in the Order

• At RFQ: ask for the registration number, last renewal date, US agent and, for acidified or low-acid canned goods, FCE and SIDs.
• At PO: make a valid registration on the shipping date and arrival date a condition, and in an even-numbered year, ask for confirmation of renewal by early December.
• Before shipping: give your broker the manufacturer's registration number for prior notice. Prior notice must be confirmed by FDA at least 8 hours before arrival by sea, 4 hours by air or rail, and 2 hours by road, and can't be filed more than 15 days ahead through FDA's own portal. Food sent by international mail needs prior notice confirmed before it's sent. Check the current timeframes with your broker.
• In your FSVP file: keep the registration details with your hazard analysis and supplier verification records.

If food from a foreign facility that should be registered arrives without a valid registration, it can be held at the port or a secure facility until the facility registers. You pay for the storage.

5. Who Handles It in India

Nobody in India issues FDA registration. No Indian authority (FSSAI, APEDA, EIC) files it for you. The plant files directly in FDA Industry Systems, or authorises someone to file for it, often the US agent. A DUNS number comes from Dun & Bradstreet, through its Indian operation or its website.

There are plenty of consultants in India who file registrations for a fee, and some of them do a decent job. But FDA says registrants are not required to use a third-party "registrar", and there's no FDA fee to register. What does cost money is a US agent service, if you don't have a US partner who can act as one.

6. How an Indian Exporter Registers

Step 1 - Get a DUNS number for the plant. Use the exact legal name and plant address you'll put in the FDA registration. FDA verifies the address against the DUNS record. Start early, because it can take weeks, and fix any mismatch with D&B before you file.

Step 2 - Line up a US agent. It has to be a person or company that lives or works in the US and is physically present there. Your US importer can sometimes act, or you can use a paid agent service. FDA will email them to confirm, and they have 30 days to answer, or your submission is removed.

Step 3 - Create an FDA Industry Systems account. Open an account in FIS and choose Food Facility Registration. Use a shared company email, not one person's inbox, so renewals don't depend on someone who might leave.

Step 4 - Fill in the registration. You'll give the facility name, address, DUNS number, parent company, emergency contact, the US agent's details, the food product categories you make or hold, and an assurance that FDA may inspect the facility. Every trade name the plant uses goes in too.

Step 5 - Submit and wait for verification. FDA checks the DUNS and the address, and the US agent's confirmation, before it confirms the registration and issues the number. This is usually quick when the DUNS record matches, and slow when it doesn't.

Step 6 - Keep a copy. FDA treats a copy of a valid registration as the proof. Don't buy a certificate.

Step 7 - Add FCE and SID if you make acidified or low-acid canned food. Register the establishment as a food canning establishment and file a scheduled process for each product, prepared by a process authority. These are separate filings in FDA's systems and they take longer than the facility registration, so do them first if your range includes pickles, sauces or canned drinks.

Step 8 - Update within 60 days of any change. New owner, new US agent, new product category or a new emergency contact must be updated within 60 days. A new owner must cancel the old registration and register again.

Step 9 - Renew in every even-numbered year. Renew between 1 October and 31 December. If nothing has changed, the renewal is abbreviated. If you miss it, the registration expires and you register again from scratch.

Common reasons registrations fail - a DUNS address that doesn't match, a US agent who never answers FDA's email, and a registration filed under a trader's office address instead of the plant.

What to send the buyer - the registration number, the US agent's name and contact, the renewal date, your DUNS number and, where it applies, the FCE number and the SIDs for their products. Their FSVP file needs it.

If you'd like someone to handle the agent, the DUNS record and the FDA filings for your suppliers, SourcingSync (opens in a new tab) can take that on.

7. A Worked Example With Mango Pickle for a New Jersey Distributor

This example is an illustration built from the rules above, not a real firm.

A New Jersey distributor wants mango pickle and lime pickle from a maker in Gujarat. The maker shows a "certificate" with an FDA logo and a registration number.

The certificate is meaningless, so the distributor asks for the plain facts instead. The registration number, last renewed in December 2024, so it must be renewed by 31 December 2026. The DUNS number, which matches the plant address. The US agent, a compliance firm in New York. All good so far.

Then the product question. Pickles are acidified foods, the same group behind most of those 145 refusal lines, so the distributor asks for the FCE number and a SID for each pickle. The maker has an FCE number but filed a process only for mango pickle. Lime pickle would be refused at the port. The order goes ahead for mango only, the maker files the lime process with its process authority, and lime joins the second order. That's one email that saved a container.

FAQ

8. Next Steps

• For the US border's history on Indian food, read FDA import alerts.
• For test plans for the same goods, read food import testing.
• For the US market page, see India to the US.
• For the export registrations your supplier needs in India, see IEC, RCMC and export registrations.
• For every certificate guide, go to certifications.