10 FDA Compliance Errors That You Can Avoid

10 FDA Compliance Errors That You Can Avoid

The U.S. Food and Drug Administration (FDA) published a list of Common Entry Errors which result in delays at the border while they are reviewed and manually corrected.

Oftentimes with food-related imports, the culprit of those pesky border delays can be traced back to one or more of these top 10 Food and Drug Administration (FDA) compliance errors. Understanding what they are and why they are happening can help you mitigate future delays. 

Top FDA Compliance Errors

The Shipper is not necessarily the Manufacturer: Often the Shippers information is used in place of the actual manufacturer's name, address, and FDA registration number. It’s important to understand the distinction between the two. The Shipper is the foreign company location in which the goods begin their journey into the U.S. The Manufacturer is the company that creates, produces, or grows the goods. 

Example: A blueberry grower from BC hires a shipper to transport their blueberries into the U.S. The FDA data elements for the Manufacture would be the grower, and the Shipper details would be the company in the foreign country where the carrier picks up the berries. 

Missing documents & A of C Identifiers: If you are importing devices, medications, or FDA products that require special registration then you need to make sure that information is included in every individual declaration. These documents and identifiers are submitted to FDA in your entry as Affirmation of Compliance (AofC) codes, which are used as confirmation that the goods meet specific requirements of entry. If the wrong AofC code is used, or not all AofC codes are listed, it will likely cause the shipment to be delayed while the FDA investigates.

Incorrect FDA Product Code: This code tells the FDA what the product is, how it is packaged (i.e. plastic, cardboard, etc.), and what the temperature of the product should be. You will need to make sure that your product’s invoice descriptions detail these three things to ensure that your FDA product codes are correct.

Incorrect Shipper: Often the Shipper may be exporting products from multiple Manufacturers. If this is the case for your goods, you must make sure that the invoice declares the correct Shipper and on the individual invoice lines of product lists the specific Manufacturer for the product.

Inaccurate Quantities: The FDA wants to know the quantity count down to the smallest package for the piece count for packaged goods, and the weight for bulk orders. Often on packaged shipments importers will merely list a weight. However, the FDA wants to know the number of pieces, and the weight of each of those packages.

Inaccurate or Incomplete Product Descriptions: Vague product descriptions can be the bane of the entry process. You want to make sure your descriptions are as detailed as possible so that the product can be easily identified at the time of inspection. Vague descriptions can lead to a whole shipment being held by the FDA, whereas detailed descriptions may allow for a majority of the shipment to be released while FDA reviews specific products. Do not use product codes as a description.

Inaccurate Device Initial Importer: Oftentimes, a device exported from foreign manufacture is sent to a company that will further market the goods and will make the final sale to the buyer. This is referred to as the Device Initial Importer, who must be listed in the declaration to Customs. This is not to be confused with a repackager or labeler.

Incorrect Consignee: While U.S. Customs’ main focus is on the parties to the transaction, meaning who is issuing and paying the bill, the FDA wants to know where that product is physically being delivered. This allows them to track the supply chain and conduct inspections efficiently.

Incorrect Valuation: Incorrect value is another common error for both FDA filings and U.S. Customs entries. If the incorrect value is provided to the FDA, the duty and tax calculated could be incorrect, as will the penalty!

For tips on how to accurately value your goods for U.S. Customs, check out our blog on the Methods of Valuation.

Intended Use: Again this pairs with the product description and FDA product code. You want to make sure the intended use of the product is clear so that it can be coded, inspected, and released quickly.

Labeling: You want to make sure your products are labeled correctly and in line with U.S. Customs and Border Protection (CBP) and FDA's labeling rules. 

Are your carriers experienced re-occurring delays for any of the errors above? Give us a call to discuss how we can analyze your import documents before the declaration to avoid such delays in the future. 1-888-538-1566.

6 Methods Of Determining Customs Valuation
Have questions about compliance regulations?
Share this post
About Author
Misty Gibbins

Misty has been working in the brokerage business for 36 years. She was the manager of the Blaine Office of Peace Bridge Customs Brokers for nine years, before coming to Pacific Customs Brokers Inc. US operation. Misty has worked in the trade compliance group at PCB for the past 13 years. She is currently the Senior Trade Regulatory Analyst, which involves keeping up with trade related regulatory changes.

While we strive for accuracy in all our communications, as the Importer of Record it is incumbent upon your company to ensure that you are aware of the requirements under the new regulations so that you maintain compliance as always.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.