Overview
FDA Overview
Procedures for an FDA Importation to the United States
“…All imported products are required to meet the same standards as domestic goods. Imported foods must be pure, wholesome, safe to eat, and produced under sanitary conditions…”
Go to the FDA website- Make an invoice stating the following:
- Description of product
- Quantity of product
- Weight of product
- Value of product
- State who the manufacturer or grower is if different from shipper for every product in the invoice.
- State who is the consignee or the entity that receives each product if different than the importer.
- Before sending Invoice to Rancho Customs Brokers double check that all information on the invoice is correct.
- Have all original invoices (Original Manufacturer or Grower invoices) available for FDA purposes.
- Monitor your entry via email or Rancho Customs Brokers’ “Tracking system”
- For email, you will be receiving Customs and FDA notifications via email while your entry is being analyzed both by CBP and FDA.
- For Tracking System, you will receive a user name and password and once you log on our website you will be able to log on our portal to see CBP and FDA responses.
- For more information regarding ITACS visit our website and download the ITACS presentation.
- Follow all FDA responses and directions. For each entry you will receive one or more of the following messages:
- FDA REVIEW:
- Entry is not released for distribution. Please wait for FDA MAY PROCEED or FDA RELEASE for distribution.
- If you see FDA REVIEW it means FDA has not decided whether they will examine or release your entry. It probably means that FDA has not been able to analyze your entry.
- In the meantime, even if truck has been released by CBP, please HOLD the product until further notice from FDA.
- FDA HOLD:
- Entry is not released for distribution. Please wait for FDA MAY PROCEED or FDA RELEASE for distribution.
- If you see FDA HOLD, FDA wants to see documentation, and upon review of documents FDA will decide whether or not they want to physically examine the entry.
- In the meantime, even if truck has been released by CBP, please HOLD the product until further notice from FDA.
- FDA EXAM:
- FDA has decided to physically examine your entry.
- FDA will perform either a FIELD EXAMINATION and product is not sent to a lab but reviewed at the port at the time of importation.
- Or FDA will perform a LAB ANALYSIS and samples are taken and sent to the FDA LAB for a Macro analysis (Pesticides) or Micro analysis (Pathogen Contamination “Salmonella or Ecolai”)
- Whichever way FDA decides to go on your Entry EXAM, you must HOLD all product examined intact until FDA RELEASED.
- FDA MAY PROCEED
- FDA has decided your entry MAY PROCEED into the commerce of the United States and is ready for distribution.
- FDA REVIEW:
- Go on ITACS to follow the FDA Status of your entry.
- Import Trade Auxiliary Communication System (ITACS)
- ITACS is available on our website www.ranchocustomsbrokers.com to follow up on your FDA entry.
- If you have any questions at any point please contact us at Rancho Customs Brokers and we are more than happy to help answer any questions concerning your entry.