| Title: | FDA TO REJECT UNKNOWN/CONSOLIDATED CONSIGNEES MARCH 21 |
|---|---|
| Date: | 2005-03-11 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS
FROM: THE FOOD & DRUG ADMINISTRATION
SUBJECT: FDA TO REJECT ENTRIES WITH AN UNKNOWN OR CONSOLIDATED
CONSIGNEE AND ABI WP'S TRANSMITTED WITH ZEROES FOR
THE CONSIGNEE NUMBER
BEGINNING MARCH 21, 2005, FDA WILL BEGIN REJECTING ANY ENTRY CONTAINING
PRIOR NOTICE DATA WHEN ONE OR MORE LINES ARE TRANSMITTED WITH AN
UNKNOWN OR CONSOLIDATED ULTIMATE CONSIGNEE.
ADMINISTRATIVE MESSAGE 04-1779 DATED AUGUST 10, 2004, PREVIOUSLY
ANNOUNCED ADDITIONAL PLANNED PRIOR NOTICE EDITS AND VALIDATIONS TO
BECOME EFFECTIVE AUGUST 13, 2004. ITEM 4 OF THAT MESSAGE INDICATED
"WHEN SUBMITTING A CONSOLIDATED CONSIGNEE WITH THE ENTRY, THE FILER
MUST REPORT THE FDA ESTABLISHMENT IDENTIFIER (FEI) AT THE FDA LINE
LEVEL IN POSITIONS 15-26 OF THE FD03 RECORD.
"FDA REJECT REASON CODES" WERE DESCRIBED IN THE SAME ADMINISTRATIVE
MESSAGE. THE CODES APPEAR IN THE BN APPLICATION FD02 RECORD IN
POSITIONS 64 THROUGH 78. THE REJECT FOR UNKNOWN/CONSOLIDATED CONSIGNEE
WILL BE A "U" IN POSITION 70.
FDA WILL ALSO BEGIN REJECTING PRIOR NOTICE SUBMISSIONS SUPPLIED VIA
ABI'S WP TRANSACTION WHEN ZEROES ARE TRANSMITTED IN THE "CON"
AFFIRMATION OF COMPLIANCE INSTEAD OF THE CONSIGNEE'S ACTUAL NUMBER.
ANY QUESTION ABOUT THE SUBMISSION AND/OR FORMATTING OF FDA LINE LEVEL
CONSIGNEE INFORMATION SHOULD BE REFERRED TO YOUR ASSIGNED ABI CLIENT
REPRESENTATIVE.
THE FOOD & DRUG ADMINISTRATION