OASIS_Fact_Sheet_3-28-17_clean.doc

The Operational and Administrative System for Import Support (OASIS) is an FDA application that has allowed staff to process entries since 1999. Initial admissibility decisions are now made in the Entry Review application; however the remainder of the admissibility process is still conducted in OASIS.

OASIS conducts secondary line screening after PREDICT has finished its screening process. If neither PREDICT nor OASIS recommends a line be held for manual review, it will be issued a May Proceed.

OASIS is used by Field Investigators to record the results of field work such as physical examinations and sample collections. If no violations of the Food, Drug & Cosmetic Act are observed at the time of examination, OASIS allows the Investigator to issue a release. If a line is not released, it is referred to the compliance branch.

Compliance Officers record their work and make both intermediate and final admissibility decisions such as releases, detentions and refusals.

Additionally, OASIS supports compliance activities such as recording the outcomes of submission of non-FDA laboratory analytical packages as well as tracking stages of the reconditioning process.

OASIS is used to track some post-refusal activities including supervision of exportation or destruction.

In addition to supporting the admissibility process, Notices of FDA Action are generated and printed from within OASIS. Additional internal administrative functions are also conducted in OASIS.

OASIS provides users the capability to view documents submitted by trade via ITACS, as well as the ability to upload their own documents.

IMPORTS�FACT SHEET March 28, 2017

Helpful Links

� HYPERLINK "http://inside.fda.gov:9003/downloads/ORA/OfficeofRegionalOperations/OfficeofEnforcement/DivisionofImportOperationsandPolicy/UCM316013.pdf" ��PREDICT FACT SHEET�

� HYPERLINK "http://inside.fda.gov:9003/downloads/ORA/OfficeofRegionalOperations/OfficeofEnforcement/DivisionofImportOperationsandPolicy/UCM316014.pdf" ��ITACS FACT SHEET�

� HYPERLINK "http://www.fda.gov/downloads/internationalprograms/newsevents/ucm392664.pdf" ��Import Program Overview�