FDA’s Filer Evaluation Program
In order to participate in FDA’s electronic import entry filing and screening system (Operational Administrative System for Import Support – “OASIS”), Customs brokers or filers often find themselves subjected to an FDA audit process the agency calls its "Filer Evaluation Program".
Other than persons that transmit prior notice to FDA (through Customs’ entry processing system), FDA law does not grant FDA jurisdiction over Customs brokers. Nevertheless, in order to participate in OASIS, most filers have undergone one or more Filer Evaluations.
In this process, FDA inspectors compare electronically filed or transmitted entry information into OASIS with the documentation that underlies the transmission. Where FDA finds too many errors (according to the agency’s unpublished procedure and criteria), filers could be placed on "dual filing" status. Dual filers are required to submit paper records for each electronically filed entry until FDA is “satisfied” that the filer can participate in the program with an “acceptable” error rate.
FDA's filer evaluation procedures and criteria are unpublished.
FDAImports.com founder Benjamin England understands the underlying principles involved in FDA's filer evaluations. His unique involvement in overseeing the program uniquely suits him to assist customs brokers in preparing for and properly managing the FDA filer evaluation process and its outcomes.
