FDA Import Refusal Report Scraper

Scrapes the FDA Import Refusal Report — every shipment refused US border entry. Returns manufacturer details, product codes, FD&C charge codes, and refusal dates. Essential for customs brokers and supply-chain compliance teams monitoring FDA refusals monthly.

What it does

The FDA Import Refusal Report tracks every shipment refused entry into the United States. This actor scrapes that public database from the FDA's Access Data portal and returns structured records for each refusal.

Each record includes:

• Manufacturer details (name, FEI number, address, country)
• Product code and FDA product description
• Refusal date and FDA district
• Entry, document, line, and suffix identifiers
• Whether FDA sample analysis or private lab analysis was conducted
• Violation charge codes (statute section + charge statement)

Input

Field	Type	Default	Description
maxItems	integer	10	Maximum number of records to return. Set to 0 for all records.
month	integer	current month	Month number (1–12) to scrape.
year	integer	current year	Year to scrape (e.g. 2026).
country_code	string	(all)	Optional ISO 2-letter country code filter (e.g. CN for China, IN for India).

Example input — China refusals for May 2026

{
  "maxItems": 100,
  "month": 5,
  "year": 2026,
  "country_code": "CN"
}

Example input — All countries for a month

{
  "maxItems": 500,
  "month": 4,
  "year": 2026
}

Output

Each dataset item is a single FDA import refusal record:

{
  "entry_id": "NVB-4019665-3",
  "doc_id": "610003",
  "line_number": "2",
  "suffix": "",
  "fei_number": "3030647202",
  "firm_legal_name": "Guangdong Wanzhuang Cosmetics Co., Ltd.",
  "address_line1": "No. 3, Zhongzhai Industrial District",
  "address_line2": "Heping Town, Chaoyang District",
  "city": "Shantou",
  "state_province": "Guangdong",
  "country_name": "China",
  "product_code": "53CC03",
  "product_code_description": "EYE SHADOW (EYE MAKEUP PREPARATIONS)",
  "refusal_date": "01-May-2026",
  "district": "DSEI",
  "entry_doc_line_sfx": "NVB-4019665-3/610003/2",
  "fda_sample_analysis": "No",
  "private_lab_analysis": "No",
  "refusal_charges": ["CGMP|21 USC 331(a)|The article appears to be adulterated..."],
  "first_seen": "2026-06-23T02:07:05.611Z"
}

Use cases

• Customs compliance: Monitor whether your suppliers appear in the FDA refusal list before shipments depart.
• Supply chain due diligence: Screen manufacturers by country or product code for regulatory risk.
• Competitive intelligence: Track refusal trends by product category or country of origin.
• Regulatory research: Build a historical database of FDA import actions for analysis.

Notes

• Data availability: The FDA typically publishes refusal data for a month within the first 1–2 weeks of the following month. If the actor returns no results for the current month, try the previous month.
• Rate limiting: The actor applies a 500ms courtesy delay between requests to avoid overloading the government server.
• Proxy: No proxy required — the FDA's Access Data portal serves all IP addresses without restriction.
• Monthly scope: To retrieve all refusals for a full month across all countries, set maxItems: 0. Expect 500–5,000 records per month depending on the month and year.

Data source

FDA Import Refusal Reports — U.S. Food and Drug Administration, public domain.