Navigating FDA Import Detentions: A Comprehensive Training Resource

The FDA import detention process can be a daunting 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, import detentions can be successfully resolved, allowing businesses to maintain compliance with FDA regulations and resume their import operations. This training resource aims to equip importers, regulatory affairs professionals, and other stakeholders with the necessary information and strategies to navigate FDA import detentions effectively.

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.

• 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. 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):

Next, it is important to develop the corrective action plan. This will include:

• 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.

• Prioritizing corrective actions based on severity and potential impact on product safety and compliance.

• 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:

• Thereafter, the Company must collect and organize all relevant documentation, including product specifications, manufacturing records, laboratory test results, and quality control procedures.

• The Company must ensure that all documentation is accurate, complete, and readily accessible for review by FDA inspectors.

• Submission of Response to FDA:

• Next, the Company will need to prepare a comprehensive response to the FDA, addressing each compliance issue identified and providing supporting documentation and evidence of corrective actions taken.

• The Company must clearly articulate how the proposed corrective actions will address the root causes of non-compliance and prevent recurrence in the future.

• 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.

• Implementation of Corrective Actions:

• It is important for the Company to execute the CAP according to the established timelines, ensuring that all corrective actions are implemented effectively and documented appropriately.

• The Company must also conduct internal audits or inspections to verify compliance with FDA regulations and the effectiveness of corrective measures.

• Re-Submission and Clearance:

Once all corrective actions have been implemented, we recommend submitting a request for re-inspection or re-evaluation to the FDA as needed and based on the detention charges, providing evidence of compliance and addressing any remaining concerns.

• Continuous Improvement: Upon successful resolution of the import detention, we recommend conducting a thorough review of the incident to identify lessons learned and opportunities for process improvement to prevent similar issues in the future.

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. By following the guidelines outlined in this training resource and leveraging the expertise of regulatory professionals, 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 FDA and/or Customs compliance questions including FDA import best practices, please contact us at info@garg-law.com.