| Title: | PRIOR NOTICE REJECTS |
|---|---|
| Date: | 2005-06-21 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS
FROM: CBP CLIENT REPRESENTATIVE BRANCH
FOOD & DRUG ADMINISTRATION
SUBJECT: REPETITIVE PRIOR NOTICE REJECTS
REFERENCE: ADMINISTRATIVE MESSAGES: 03-2619, 03-2625, 04-1779
04-2355, 04-2525, 05-0019, 05-0110, 05-0216, 05-0312,
05-0580
CBP AND FDA CONTINUE TO RECEIVE REPETITIVE PRIOR NOTICE REJECTS
ON A DAILY BASIS FROM BASICALLY THE SAME FILERS. THIS DESPITE THE
ADMINISTRATIVE MESSAGES REFERENCED ABOVE DETAILING THE REJECTS AND HOW
TO AVOID THEM. EVERY FILER'S HEADQUARTER'S OFFICE IS RESPONSIBLE FOR
ASSURING THAT INDIVIDUAL OFFICES READ ADMINISTRATIVE MESSAGES. IT IS
OBVIOUS FROM THE REPETITIVE NATURE OF THE PRIOR NOTICE REJECTS WE ARE
SEEING THAT ALL OFFICES ARE NOT READING THESE MESSAGES.
PLEASE ENSURE THAT ALL OFFICES READ THESE MESSAGES!!!!!
MOST OF THE REJECTS ARE IN THE AREA OF REGISTRATION REJECTS. THIS IS
REJECT REASON 2, POSTION 65 OF THE BN02 RECORD. THE MOST COMMON REJECT
IS THE "M" "MISMATCH IN REGISTRATION" ERROR. THIS OCCURS WHEN THE FDA
MANUFACTURER (MID) DOES NOT MATCH THE 'PFR' PRIOR NOTICE REGISTRATION
EITHER THE ISO COUNTRY OF ORIGIN, NAME OR ADDRESS. YOU MUST CHECK
THESE TWO BEFORE SENDING THE ENTRY.
IF YOU HAVE ANY QUESTIONS ABOUT THE REGISTRATION NUMBER YOU SHOULD
CALL FDA'S FURLS REGISTRATION DESK AT 1-800-216-7331.
CBP CLIENT REPRESENTATIVE BRANCH
FOOD & DRUG ADMINISTRATION
JOHN OGLIORE, SEATTLE TRADE SUPPORT (206) 553-5228