FDA Import Actions & Enforcement Services

When a product faces FDA import delays, detentions, or refusals, it means the FDA has identified a potential violation of regulations. These actions can disrupt your business by blocking shipments or delaying your product’s entry into the U.S.

How We Help You Navigate FDA Import Actions

At FDA Import Insights, we support businesses by helping them overcome these challenges with a clear and straightforward process to resolve FDA compliance issues.

To avoid or clear detentions and refusals, the process typically requires:
✅ Examination & Sample Collection – We ensure your products are available for FDA examination and handle communication with the FDA to prevent delays.
✅ Detention Mitigation – If your product is detained, we guide you through the process of providing evidence and documentation to resolve the issue.
✅ Refusal Resolution – We assist in addressing reasons for refusal, such as adulteration or misbranding, and offer solutions to meet FDA requirements.
✅ Enforcement Action Support – If facing additional actions like seizures or penalties, we help mitigate these risks by providing expert advice on compliance and corrective steps. We streamline the process, ensuring that you meet all necessary requirements and avoid costly delays or refusals.

Need Assistance?
Contact us today to prevent import disruptions and ensure smooth FDA compliance for your shipments.