The FDA Import Detention Marathon

Welcome to the FDA import detention merry-go-round, where we say, hold onto your paperwork!

The FDA import detention process can be a daunting (and let’s be honest, derailing!) experience for businesses involved in importing goods, especially those in the realm of foods, cosmetics, dietary supplements, drugs or medical devices. However, with proper knowledge and strategic planning, the import detention marathon can be successfully resolved, allowing businesses to maintain compliance with FDA regulations and resume their import operations. We’ll address here strategies for importers, regulatory affairs professionals and other stakeholders to navigate FDA import detentions effectively and timely, to get back on track.

Understanding FDA Import Detentions:

• What is FDA Import Detention? When products in your shipment (e.g. the entire shipment or a specific line entry) violate or appear to violate FDA laws and regulations, FDA may detain your product and issue a “Notice of FDA Action” identifying the shipment as “Detained.” This Notice is considered the Notice of Detention and Hearing.

• Causes of Import Detentions: Import detentions can occur due to various reasons, including non-compliance with FDA regulations, such as mislabeling, adulteration, contamination, or failure to provide required documentation.

• Types of Import Detentions: FDA import detentions can result in “Refusal of Admission” or “Import Alert,” preventing the entry of goods into the United States until compliance issues are resolved. The FDA may also issue a “Notice of Hold” or “Notice of Sampling” prior to issuing an FDA Notice of Detention.

• Consequences of Import Detentions: Import detentions can lead to financial losses, delays in product distribution, damage to business reputation, and potential legal consequences if not resolved promptly and effectively.

Resolving FDA Import Detentions:

• Communication with FDA: Upon receiving a detention notice, we recommend promptly establishing communication with the FDA to understand the reasons for detention and gather information about the specific issues identified. We strongly recommend having legal experts experienced in FDA regulations and import detention resolution processes to provide guidance and support including but not limited to directly communicating with FDA on behalf of your Company, asking the right questions, identifying the issues, and preliminarily assessing the compliance questions. Sometimes, FDA can admittedly get it wrong. It is therefore important to assess the issues with counsel to determine the proper compliance issues and begin to develop a response. This can save time, expense and further delays in the entry process.

• Assessment of Compliance Issues: We then recommend conducting a thorough internal assessment to identify the root causes of non-compliance and assess the scope of corrective actions required.

• Development of Corrective Action Plan (CAP): This includes formulating a comprehensive CAP outlining specific steps to address each compliance issue identified by the FDA. For example, this may include reconditioning the product to correct the violation. This also includes prioritizing corrective actions based on severity and potential impact on product safety and compliance, and assigning responsibilities to relevant personnel and establishing clear timelines for implementation.

Note that if you are not able to overcome the appearance of a violation, FDA will issue a Notice of Refusal of admission for the product. You must then work with CBP and FDA to destroy the product or export it from the U.S. within 90 days of the refusal. It is important to timely comply with these deadlines to avoid penalties, also known as liquidated damages. More information on CBP Liquidated Damages can be found here and here.

• Documentation and Evidence Gathering, FDA Submission of Response: The Company must then collect and organize all relevant documentation, including product specifications, manufacturing records, laboratory test results, and quality control procedures. We recommend the Company prepare a detailed response to FDA, addressing each compliance issue identified and providing supporting documentation and evidence of corrective actions taken.

• Follow-Up and Continued Communication: We recommend that the Company maintain open and proactive communication with the FDA throughout the resolution process, providing regular updates on the progress of corrective actions. We also recommend the Company respond promptly to any additional inquiries or requests for information from FDA inspectors.

Successfully resolving FDA import detentions requires a proactive and systematic approach, encompassing effective communication with FDA authorities, thorough assessment of compliance issues, development of comprehensive corrective action plans, and diligent implementation of corrective measures.

Despite this, it’s important to note that FDA Detentions are a bump in the road, and present an opportunity to (1) pushback on the Detention notice based on a thorough and well-documented assessment of U.S. laws and regulations; (2) identify the issues, implement changes, and develop CAPAs; and (3) to get better as a Company. By having systems in place, businesses can navigate import detentions with confidence, ensuring compliance with FDA regulations and safeguarding their import operations and reputation.

For assistance with an FDA import detention, FDA import refusal, Import Alert, or other U.S. FDA and/or Customs compliance questions including FDA import best practices, please contact us at info@garg-law.com.