5 Recurring Reasons for FDA Clearance Delays and a Tool to Help

Posted by Jim Conrad
Blog originally posted on 12/06/2023 07:45 AM

5 Reasons for FDA Clearance Delays and a Tool to Help_Blog Header

The U.S. Food and Drug Administration (FDA) is responsible for ensuring that all food, drugs, and medical devices imported into the United States meet the country's safety and quality standards. However, there are times when FDA import clearance delays occur, causing frustration for importers. Some of the most common reasons for delay include:

  1. Documentation Errors: Importers are required to provide accurate and complete documentation when importing food, drugs, and medical devices into the United States. Inadequate descriptions, data errors, or omissions in the documentation can delay the clearance process.

  2. Product Mislabeling: The FDA requires that all products have accurate and clear labeling that includes information such as ingredients, nutrition facts, registration information when required, and warning statements. Labels must not contain false or misleading information, and some products must be registered prior to importation.

  3. Adulterated Products: If the FDA determines that a product is unsafe, unfit for consumption, or does not otherwise meet applicable standards, it may be denied entry into the United States. In some cases, the FDA may allow corrective action to bring the product into compliance. However, the adulterated product will often be required to be exported or destroyed.

  4. Restricted Products: Product importation may be delayed or refused entry for unapproved new drugs and medical devices or for products that are forbidden or restricted for sale.

  5. Increased Scrutiny: Some products may be subject to increased scrutiny due to safety concerns or regulatory changes. This can cause delays in the clearance process as the FDA may require additional testing or documentation to ensure the product’s safety.


How Affirmation of Compliance Codes Help Expedite the Process

All FDA-regulated products are expected to comply at the time of entry. Affirmation of Compliance codes can help in the FDA import clearance process. To help expedite FDA’s review, the entry filer can submit additional information at the time of entry, such as registration, listing, and approval numbers. This information can be submitted by using Affirmation of Compliance (AoC) codes.

By using an A of C code, the importer affirms that the firm and/or product identified in an FDA line meets the requirements specific to each code. While most are voluntary, they are highly recommended to ensure FDA has the proper data to screen and release a shipment.



Most shipment delays related to the Food and Drug Administration are due to omitted or unclear data submitted at the time of importation. Errors associated with an importer of record can compound, increasing the importer’s risk score and risk of further holds. Proper due diligence before importation can save time and money. In all areas, Tradewin is here to help.

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Topics: Import Consulting

Blog originally posted on 12/06/2023 07:45 AM

Jim Conrad

Written by Jim Conrad

Jim joined Tradewin in 2009, continuing a successful career in international logistics and trade compliance that began in 1980. He has spent more than three decades in leadership roles overseeing international trade compliance including the positions of corporate Director of Operations and as Chairman of the Board of Directors for a large U.S. shipper’s association. Jim’s technical background covers a wide range of international trade areas including harmonized tariff classification, valuation, anti-dumping and risk analysis. Jim is a graduate of North Shore Community College and majored in Business Administration at Salem State University. He is a member of the International Compliance Professionals Association and a U.S. Licensed Customs House Broker.