How does FDA review import entry information to make admissibility determinations?
After information is transmitted from CBP, OASIS screens the entry information against FDA admissibility criteria. If the FDA electronic review determines that further evaluation of the information or article is not necessary, the system transmits a message back through the FDA/CBP interface that the article “may proceed without FDA examination.” If further evaluation is necessary, FDA staff will review the entry information and may request additional information necessary to make an admissibility determination. If the FDA electronic review indicates that the product appears “by examination or otherwise” to be subject to refusal of admission under section 801(a) of the FD&C Act (e.g., appears to be adulterated or misbranded), the FDA reviewer will evaluate the entry information based on FDA guidance, take appropriate action, and notify the importer as well as the customs broker. FDA’s import regulations, which set out the process for notice and refusal, can be found at 21 CFR Part 1,
Related Questions
- I heard the FDA has announced an Import Alert concerning farm-raised shrimp from China. Where does Contessa shrimp come from?
- What are the possible determinations when a review request is sent to a physician peer reviewer?
- How does FDA review import entry information to make admissibility determinations?
