---
title: FDA Documents to Get From Your China Factory First
description: Shipping FDA-regulated goods from China? The documents to get from your factory before the container sails, and why each one matters.
image: https://www.china-agent.com/hubfs/fda-factory-documents-featured.jpg
---

[Skip to content](https://www.china-agent.com/blog/fda-documents-checklist-china-factory#main-content)

[![China Agent](https://www.china-agent.com/hs-fs/hubfs/china-agent-180-1.png?width=60&height=60&name=china-agent-180-1.png "China Agent")](https://www.china-agent.com/)

- [Home](https://www.china-agent.com)
- [About Us](https://www.china-agent.com/about-us)
- [Case Files](https://www.china-agent.com/case-files)
- Monthly Support 
    - [China Supplier Control](https://www.china-agent.com/monthly-support-packages)
    - [Your own employee in China](https://www.china-agent.com/employee-in-china)
- Fixed-Price Services 
    - [Supplier Reality Check ($95)](https://www.china-agent.com/supplier-reality-check)
    - [Due Diligence](https://www.china-agent.com/due-diligence)
    - [Contracts](https://www.china-agent.com/contracts)
    - [Guided Visits](https://www.china-agent.com/guided-visits)
    - [Fixer](https://www.china-agent.com/fixer)
- [Blog](https://www.china-agent.com/blog)
- [Contact Us](https://www.china-agent.com/contact-us)

- [Book a call](https://www.china-agent.com/booking)
- [Or WhatsApp us](https://wa.me/8615322086875)

# FDA Documents to Get From Your China Factory First

![](https://www.china-agent.com/hubfs/fda-factory-documents-featured.jpg)

- November 4, 2026

![Eldad Shashua](https://www.china-agent.com/hubfs/Eldad%20Shashua.jpeg)

[Eldad Shashua](https://www.china-agent.com/blog/author/eldad-shashua)

**Short answer:** Get proof of who really makes the goods, the factory's FDA registration and FEI, the spec sheet, the final label, test reports and a written note of any changes. Then make sure the invoice, the label and the spec sheet all describe the same product. Most holds we see start with papers that don't match.

Most factories will give you these papers if you ask clearly and early. The trouble is that nobody asks. FDA and CBP both read the same product facts, and those facts are written in China. Here is the list.

## Who makes it

- **Business license of the actual factory**, not only the trading company. If the shipper is a trading company, get the name and address of the factory behind it.
- **FDA registration and FEI number** for the facility that made the goods, with a name and address that match the license.
- **The factory's FDA history.** Look the maker up on FDA's [import alerts](https://www.accessdata.fda.gov/cms_ia/country_CN.html) and [refusal records](https://www.accessdata.fda.gov/scripts/importrefusals/) before you order and again at every reorder.
- **Device listing or 510(k) details**, if it is a medical device.

## What it is

- **Spec sheet** with materials, formula or bill of materials.
- **Final label, insert and packaging artwork**, approved before printing. Watch for health or medical claims; they can change which FDA category the product falls in.
- **Test reports** that match this product and this batch.

## What the papers say

- **Commercial invoice and packing list** with a product description that matches the spec sheet and the label.
- **HTS code and FDA product code, chosen together**, with a short written reason. Your broker and counsel make the call; the factory's papers have to support it.

## What changed

- **Written change notice** for any new sub-supplier, production line, formula or label since the last order. Put this duty in your contract.

## Before the container sails

- **Put everything side by side**: factory, forwarder, broker and your US files. One set of facts, one story.
- **Introduce your FDA advisor, your broker and your trade counsel** to each other early, before there is a problem.

Getting this right takes some work and some cost. It is still far easier before shipping than after a hold.

Want to know which products FDA flags most? See [the China product categories most exposed to FDA holds](https://www.china-agent.com/blog/china-products-most-exposed-fda-holds). Already held? Read [what to do when FDA and CBP hold the same shipment](https://www.china-agent.com/blog/fda-cbp-hold-same-shipment-china), or [book a free 30-minute call](https://www.china-agent.com/booking).

China Agent has worked on the client side in China since 2009 and is not a law firm. Your broker files the entry, you certify it, and legal questions go to counsel or a trade lawyer.

 Blog Post

## Related Articles

[![](https://www.china-agent.com/hubfs/fda-exposed-products-featured.jpg)](https://www.china-agent.com/blog/china-products-most-exposed-fda-holds)

### [China Products Most Exposed to FDA Holds (2026 Data)](https://www.china-agent.com/blog/china-products-most-exposed-fda-holds)

 November 2, 2026

 Short answer: Going by FDA's own data, medical devices, tobacco and vape products, foods, drugs and cosmetics carry the...

[Read more](https://www.china-agent.com/blog/china-products-most-exposed-fda-holds)

[Knowledge Hub](https://www.china-agent.com/blog/tag/knowledge-hub)

### [Factory or Trading Company? 8 Ways to Verify Before You Scale](https://www.china-agent.com/blog/real-factory-or-trading-company)

 October 1, 2026

 To tell a real factory from a trading company, look for the same answer in four places: the business scope on the...

[Read more](https://www.china-agent.com/blog/real-factory-or-trading-company)

[![](https://www.china-agent.com/hubfs/fda-cbp-hold-featured-brand.jpg)](https://www.china-agent.com/blog/fda-cbp-hold-same-shipment-china)

### [FDA and CBP Hold the Same China Shipment: What to Do](https://www.china-agent.com/blog/fda-cbp-hold-same-shipment-china)

 November 1, 2026

 Short answer: It is stressful, but it is manageable. Two agencies are asking two questions about the same product....

[Read more](https://www.china-agent.com/blog/fda-cbp-hold-same-shipment-china)

[Check all articles](https://www.china-agent.com/blog)

 Be ready when CBP asks

### See how our Monthly Support keeps your file current, month after month and order after order.

Our management team stays on your China supplier file every month — reviewing factory records, keeping the proof CBP may ask for, and stepping in with your supplier when needed. 

[Get Monthly Support](https://www.china-agent.com/monthly-support-packages)

[![China Agent logo](https://www.china-agent.com/hs-fs/hubfs/china-agent-logo-no-tagline.png?width=600&height=465&name=china-agent-logo-no-tagline.png "China Agent logo")](https://www.china-agent.com/)

*Fixed fees. No commissions. We work only for the importer.* 

*China Agent Ltd, Hong Kong. On the client side in China since 2009, with people in Guangzhou, Foshan, Yiwu, Shenzhen and Jinan.* 

- SERVICES
- [Supplier Reality Check ($95)](https://www.china-agent.com/supplier-reality-check)
- [Due Diligence](https://www.china-agent.com/due-diligence)
- [Contracts](https://www.china-agent.com/contracts)
- [Guided Visits](https://www.china-agent.com/guided-visits)
- [Fixer](https://www.china-agent.com/fixer)
- [Monthly Support](https://www.china-agent.com/monthly-support-packages)
- [A full-time person in China working only for you](https://www.china-agent.com/employee-in-china)

- LEARN
- [Case Files](https://www.china-agent.com/case-files)
- [The Eldad Method](https://www.china-agent.com/the-eldad-method)
- [The 10 Truths](https://www.china-agent.com/the-10-truths)
- [UFLPA Detention: What CBP Wants and Your 30 Days](https://www.china-agent.com/uflpa-detention-documentation)
- [CF-28 / CF-29: When CBP Questions an Entry](https://www.china-agent.com/cf-28-response-china)
- [China Origin via Cambodia or Vietnam](https://www.china-agent.com/country-of-origin-china-vietnam)
- [CBP Detained My Shipment from China](https://www.china-agent.com/cbp-detained-shipment-china)
- [The Ten Things CBP Will Ask You to Produce](https://www.china-agent.com/blog/10-things-cbp-will-ask-you-to-produce)

- COMPANY
- [About Us](https://www.china-agent.com/about-us)
- [Contact](https://www.china-agent.com/contact-us)
- [Privacy Policy](https://www.china-agent.com/privacy-policy)
- [Terms & Services](https://www.china-agent.com/terms-and-services)

---

- The Asia Agent Network
- [asia-agent.com → flagship](https://asia-agent.com)
- [vietnam-agent.com](https://vietnam-agent.com/)
- [india-agent.com](https://india-agent.com/)
- [indonesia-agent.com](https://indonesia-agent.com/)
- [bangladesh-agent.com](https://bangladesh-agent.com/)
- [malaysia-agent.com](https://malaysia-agent.com/)
- [cambodia-agent.com](https://cambodia-agent.com/)
- [GuangzhouAgent.com](https://guangzhouagent.com/)

 All Rights Reserved 2009 to 2026 China Agent Ltd, Hong Kong, Guangzhou, Foshan, Shenzhen, Yiwu and Jinan. Part of the Asia Agent network, Singapore. [Follow us on Facebook](https://www.facebook.com/chinaagentltd/) [Follow us on LinkedIn](https://cn.linkedin.com/company/guangzhou-agent) [Follow us on Instagram](https://www.instagram.com/chinaagent1/) [Email Us](mailto:hello@china-agent.com) [Follow us on Whatsapp](https://wa.me/8615322086875)

```json
{
  "@context" : "https://schema.org",
  "@type" : "BlogPosting",
  "author" : {
    "@type" : "Person",
    "name" : "Eldad Shashua",
    "url" : "https://www.china-agent.com/blog/author/eldad-shashua"
  },
  "dateModified" : "2026-11-04T20:00:01.293Z",
  "datePublished" : "2026-11-04T20:00:01.000Z",
  "headline" : "FDA Documents to Get From Your China Factory First",
  "image" : [ "https://www.china-agent.com/hubfs/fda-factory-documents-featured.jpg" ],
  "mainEntityOfPage" : {
    "@id" : "https://www.china-agent.com/blog/fda-documents-checklist-china-factory",
    "@type" : "WebPage"
  },
  "publisher" : {
    "@type" : "Organization",
    "logo" : {
      "@type" : "ImageObject",
      "url" : "https://www.china-agent.com/hubfs/ChinaAgent%20Logo%20Design%20PNG-2.png"
    }
  }
}
```

```json
{
  "@context" : "https://schema.org",
  "@id" : "https://www.china-agent.com/#organization",
  "@type" : "Organization",
  "address" : {
    "@type" : "PostalAddress",
    "addressCountry" : "HK",
    "addressLocality" : "Hong Kong"
  },
  "contactPoint" : {
    "@type" : "ContactPoint",
    "contactType" : "customer service",
    "telephone" : "+86 153 2208 6875",
    "url" : "https://wa.me/8615322086875"
  },
  "description" : "China Agent has worked on the client side in China since 2009. Today it is a Hong Kong company with people in Guangzhou, Foshan, Yiwu, Shenzhen and Jinan.",
  "founder" : {
    "@id" : "https://www.china-agent.com/the-eldad-method#eldad-shashua",
    "@type" : "Person",
    "name" : "Eldad Shashua",
    "sameAs" : "https://www.linkedin.com/in/eldad-shashua-36519040/"
  },
  "foundingDate" : "2009",
  "legalName" : "China Agent Ltd",
  "logo" : "https://www.china-agent.com/hubfs/ChinaAgent%20Logo%20Design%20PNG-2.png",
  "name" : "China Agent",
  "sameAs" : [ "https://www.linkedin.com/company/guangzhou-agent/" ],
  "url" : "https://www.china-agent.com/"
}
```