FDA Food Supply Chain Certification: From Registration to Import Compliance

Want to export food to the U.S. but are stuck with the FDA? Don't panic! Today we use the vernacular to dismantle this "life and death line". Beginners remember.FDA approval is not about issuing certificates, but about getting a market pass through registration + compliance actions. Here's a handful to get you through -

Step 1: Facility registration - everything is free without this number!

All domestic and foreign factories involved in the production, processing and packaging of food products.Must be registered with the official FDA website(Don't say you didn't know the official website is fda.gov). Watch out for a few potholes:

• ​Dunn & Bradstreet (DUNS) code is just needed!I can't even get to the registration page without it.
• Overseas enterprises must designateUnited States Agent(USG), emergency FDA only contact TA
• ​Updated every two years! Renewed in October-December of even-numbered years, miss it and go straight to cold!

Real Case: In 2024, a Shandong enterprise suffered a loss of $2 million because 32 tonnes of frozen vegetables were detained in Hong Kong due to an empty phone number of the US agent.

Step 2: Food Safety Plan - Your "Riot Manual"

Under the Food Safety Modernisation Act (FSMA).A written version of the food safety plan must be developedThe core three-piece set:

1. ​Hazard analysis: List possible biological/chemical contamination (e.g. moulds, pesticide residues)
2. ​Prophylactic control: e.g. temperature and humidity monitoring in workshops, calibration of metal detectors
3. ​corrective action: How to recall and quarantine if problems are found

Here's a lazy trick.Direct application of HACCP templates(Search "FDA HACCP Sample"), save 70% time!

Step 3: Label Compliance - Americans are serious about punctuation

​Labelling Errors Account for FDA Withholding Reasons for 53%! Focus on these:

Pay particular attention.health claim(e.g. "hypoglycaemic") must be declared in advance, otherwise they are treated as counterfeit medicines.

Level 4: Import Compliance - Even Foreign Suppliers Have to Listen to You

If you are an importer.FSVP (Foreign Supplier Verification Programme) must be implemented::

• Audit suppliers' food safety documentation annually
• ​Key!Do third-party testing of high-risk ingredients (e.g., seafood, milk powder)
• Retain all emails, test reports for at least 2 years

Last year, a Shenzhen company was caught in the crossfire: a Vietnamese supplier secretly changed the recipe without reporting, resulting in the destruction of a whole container of dried mango with excessive lead.

The Ultimate Boss: FDA Audit - This way the clearance rate increases by 90%

​80% Business Inversion Site Inspection Session! Remember the three rules for staying alive:

1. ​Document not colour-printed: all records are recorded with theLetter Size Paper(21.5×29.7cm), otherwise it will be rejected directly.
2. ​Workshop lines should be clean: Inspectors must check washrooms → changing rooms → production lines, and bins with lids are basic.
3. ​Biting the bullet and saying "I don't know" is a big no-no.: Employees must answer the SOP number when asked about the process, and it is recommended that they be given surprise training before the test

Insider tip: FDA loves Friday afternoon raids because of high weekend overtime...

Ask yourself the core question.

​Q: How long does it take to get certified? How much does it burn?​

• When there is a Dun & Bradstreet code.About 1 month(from submission to registration number)
• No Dun & Bradstreet code.Plus 45 days coding application period​
• Fees: No official registration fees, but third party testing/consulting fees of approx.20-80k(depending on product risk)

​Q: Do I have to get a U.S. agent? Can I be my own agent?​

• Overseas EnterprisesMandatory need for Miyo! and must be met:
  ✅ Native American or company
  ✅ Have a physical office (not a virtual address)
  ✅ 24-hour access to FDA phones
• Pawn yourself? Unless you have a US green card + company

​Q: How do I get my goods back if they've been impounded?​
A three-tiered life-saving strategy:

1. Labelling issues →Replacement of correct labelling within 72 hours​
2. Excess of ingredients →Provide third-party test reports to overturn cases​
3. No registration number → basically hopeless, find a destruction company to stop the damage

Editor's point of view: do not believe that "FDA certification on behalf of the package over" ghost story! Understand the rules than to spend money is important - after all, the Americans only recognize the black and white evidence of compliance, but do not care if you are "intermediary pit".