| Title: | FOREIGN-BASED CONSIGNEE IN THE FDA INTERFACE |
|---|---|
| Date: | 2004-12-13 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS
ALL ABI SOFTWARE VENDORS AND SERVICE BUREAUS
FROM: CLIENT REPRESENTATIVE BRANCH
FOOD AND DRUG ADMINISTRATION
SUBJECT: DO NOT USE A FOREIGN-BASED CONSIGNEE IN FDA PRIOR NOTICE
IN SPITE OF SEVERAL EMAILS ISSUED IN THE PAST (SEE SPECIFICALLY
ADMIN 04-0577) WARNING FILERS NOT TO TRANSMIT A FOREIGN-BASED CONSIGNEE
IN ANY ENTRY THAT INVOLVES FDA AND ESPECIALLY WHEN THE ENTRY INVOLVES
BTA PRIOR NOTICE, 366 ENTRIES HAVE BEEN REJECTED SINCE THE BEGINNING OF
PHASE FIVE OF BTA/PRIOR NOTICE ON NOVEMBER 8, 2004 FOR USE OF A
FOREIGN CONSIGNEE. THESE REJECTS ARE ESPECIALLY TIME CONSUMING AND
DIFFICULT TO CORRECT AND INVOLVE MANY STEPS IN THAT CORRECTION. THERE
IS A SIMPLE WAY TO CORRECT THIS PROBLEM AS OUTLINED IN ADMIN 04-0577,
DO NOT SEND A FOREIGN-BASED CONSIGNEE!!! WE ARE ASKING SOFTWARE
PROVIDERS TO INSTALL AN EDIT TO PREVENT THE SEND OF A FOREIGN-BASED
CONSIGNEE IN ANY FDA REGULATED ENTRY UNLESS THE FILER HAS A VALID
FDA ESTABLISHMENT IDENTIFIER (FEI) NUMBER. THIS WILL PREVENT MANY
HOURS OF AGGRAVATION.
IF YOU HAVE ANY QUESTIONS ON THIS SUBJECT PLEASE CALL CLIENT
REPRESENTATIVE JOHN OGLIORE AT 206-553-5228.
CBP CLIENT REPRESENTATIVE BRANCH
FOOD & DRUG ADMINISTRATION
CSMS #05-000019