FDA-regulated products imported into the U.S. must comply with FDA laws and regulations. FDA enforces the Federal Food, Drug and Cosmetic Act (FD&C Act) and other related act at the point of entry.
FDA is authorized to examine and collect samples of FDA regulated products offered for entry into the United States. If the FDA decides to examine or sample your shipment, a Notice of FDA Action will be issued to the importer of record, consignee, and filer. The products on hold must be held pending FDA examination and should not be distributed into commerce until the results are evaluated and shipment is released. Failure to hold your shipment might result in Customs and Border Protection (CBP) requesting redelivery. If the product appears to be in violation, the product is subject to refusal and a Notice of FDA Action will be issued. The notice will specify the nature of the violation and provide the importer an opportunity to present supporting evidence to overcome the violation, within a specified time period.
We at Ketki International LLC provide timely assistance documentary evidences to FDA for imported product release. Our consultation is based on our past experience dealing with FDA officers and strong technical and verified methods that have been recognized by FDA. We have flair in identifying what exactly is required by FDA and we have been able to sort out most of our clients import related matters in past. We have strong network with reputed laboratories with correct testing methods recognized by FDA.
Import alerts inform FDA field staff that the agency has enough evidence or other information to allow for Detention without Physical Examination (DWPE) of products subject to an import alert. Products are subject to DWPE based upon past violations. These violations could be related to the product, manufacturer, shipper and/or other information indicating the product may be in violation of FDA laws.
In order for FDA to consider removing a product and/or firm from DWPE, FDA must have evidence that the conditions that gave rise to the apparent violation have been resolved and that gives FDA confidence future entries will be in compliance with FDA laws and regulations. You may submit a petition to DIO for removal from DWPE for most import alerts. We have expertise to submit petition to FDA for product removal from import alert. We can assist you with filing petition along with all necessary documentation, evidences and corrective action plan which can convince FDA.