There are a variety of reasons why an FDA regulated product might be detained.
The product, an ingredient in the product, the manufacturer, the exporter, or the country of origin could be the subject of an import alert. Import alerts are issued by FDA when there is a history of problems with one or more of the above. Products that fall under an import alert are typically automatically detained by FDA until the issue is resolved or the product is destroyed or returned to the exporter.
FDA reviews the paperwork on all FDA regulated products that arrive at a US port of entry from another country. The products are held until that review is complete. If no issues are discovered, the product will be released. If issues are discovered, the product will be detained.
A small percentage of incoming products are held until they can be sampled and examined, tested, or both by FDA. When that review process is complete, if there are no issues, the product will be released. If issues are discovered, the product will be detained.
Products that are detained may be given time to resolve the issue upon request. If the issue(s) are resolved to FDA's satisfaction the product will be released. If FDA determines that the issue(s) cannot be resolved or they determine that they were not resolved to their satisfaction, the product must either be destroyed or returned to the exporter.
Whenever a product is detained, the importer will be given a set period of time to respond with how they intend to handle the disposition of the product. The importer must repond by the date specified by FDA. Whatever the importer decides, they must obtain approval from FDA before they can carry that out. If the importer needs additional time to assess the situation or to carry out what FDA has approved of, they can request an extension of time. Extensions are usually granted, if deamed reasonable by FDA. However, it is extremely important to work within the timeframes alloted by FDA. If FDA believes you are not working to accomplish your goals in a reasonable amount of time, the product will be rejected and must be destroyed or returned to the exporter. FDA may grant more than one extention, but each request has diminishing returns.
R. FLORA & ASSOCIATES, INC. has years of experience dealing with detentions of FDA regulated products. Sometimes the problems are easy to correct. Sometimes the issues are more difficult, but still correctable. Many times the problem is not correctable and the simplest solution is to destroy the product or return it to the exporter. And, occassionally, FDA is wrong in their assessment. Whatever the circumstance, we can assess the situation, deal with FDA on your behalf, and help you make to right decisions regarding whether or not the problem(s) can be resolved, and if they can, lead you to the best way to resolve them. We will also help you avoid repeating these problems on future shipments.
We look forward to helping you with your regulatory needs.
R. FLORA & ASSOCIATES, INC.
250 Space View Drive
Grants Pass, OR 97526-8865
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