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food & drug administration

If you are first time FDA importer, you MUST visit FDA website at to see what's the FDA's requirements for your product and suggested to ship very small amount of product for first trial shipment since most likely your first shipment will have physical examination by FDA.

You may consult to FDA Los Angeles District, import operations branch. They are located at: 22 west 6th Street, San Pedro, CA 90731;

  • Tel: 310-831-6123
  • Fax: 310-831-5659
  • Team I: Seafood, Tel: 310-831-6123 x131
  • Team II: Foods, Cosmetics & Ceramics x132
  • Team III: Drugs, Devices & Electronics x129
  • LAX Airport FDA: 310-215-2040

You, the FDA Importer, must:

  • Determine before shipment that the product to be imported is legal.
  • Have private laboratories examine samples of foods to be imported & certify the analysis of the processor. While not conclusive, these analyses might serve as an indication of the processor's ability to produce acceptable, legal products.
  • Become acquainted with FDA's legal requirements before contracting for a shipment.
  • Request assistance from the FDA District Office responsible for your port of entry.
  • Know the food importing procedure from FDA

FDA reviews importer's entry file to determine if a physical examination should be made.

  • Decision is made NOT to collect a sample, FDA sends a "FDA MAY PROCEED" to U.S. Customs via ABI. The shipment is released as far as FDA is concerned.
  • Decision is made to collect a sample based on:
  1. Nature of the product
  2. FDA priorities
  3. Past history of the commodity.
  4. FDA sends a Notice of Sampling to U.S. Customs and the importer. The shipment MUST be held intact pending further notice. A sample will be collected from the shipment in importer's warehouse. The sample is sent to FDA District laboratory for analysis.

If sample to be in compliance with FDA requirements, FDA sends a release notice to U.S. Customs and importer.

If sample appears to be in violation of the FDA & C Act and other related Act. FDA sends Customs & importer a Notice of Detention & Hearing (FDA Form FD 777)

If refused by FDA, then you MUST destroy or export the products under U.S. Customs supervision as a witness to be an evidence for destroys or exportation. Either destroys or export will cost your money to do.

To speed up release of your FDA entry, the invoice shall contain the follow information:

  • Complete and detail descriptions of products.
  • List of ingredients with percentage of each products.
  • What's kind of packing: can, paper, plastic, glass, etc...
  • How packaged: tablet, powder, capsule, buck, etc...
  • Actual manufacturer's name, address, C/O.
  • Product Registration Number (if any).
  • Product Listing Number (if any)
  • 501(K) Number (if any).
  • FCC number (if any).
  • Model Number (if any).







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