CSMS Message: 05-000312

TO: ALL ABI FILERS, ESPECIALLY FDA PRIOR NOTICE FILERS
CORRECTION TO ADMIN 05-0304

FROM: THE FOOD & DRUG ADMINISTRATION

SUBJECT: PRIOR NOTICE MANUFACTURER REGISTRATION ERRORS
REJECTION OF MANUFACTURER REGISTRATION ERRORS
CORRECTION TO ADMIN 05-0304

FDA APOLOGIZES FOR ANY MISUNDERSTANDING THE EARLIER COPY
OF THIS ADMIN MAY HAVE CAUSED. ADMIN MESSAGE 04-2563
WAS ISSUED DECEMBER 20, 2004 ADVISING THE TRADE OF
TWO ADDITIONAL REJECT REASON CODES.THEY ARE
INCORPORATED IN THE CORRECTED VERSION BELOW.

FDA CONTINUES TO MONITOR THE VALIDITY OF MANUFACTURER REGISTRATION
INFORMATION SUBMITTED AS PART OF PRIOR NOTICE. A REVIEW OF THE PRIOR
NOTICE DATA SUGGESTS THAT THERE ARE TWO MAIN ERRORS ASSOCIATED WITH
MANUFACTURER REGISTRATION INFORMATION THAT IS TRANSMITTED USING THE
"PFR" AFFIRMATION OF COMPLIANCE (A OF C) CODE AND QUALIFIER THAT WILL
RESULT IN THE PRIOR NOTICE SUBMISSION BEING REJECTED. SUBMISSIONS
ARE REJECTED EITHER BECAUSE THE MANUFACTURER REGISTRATION NUMBER
PROVIDED IS NOT ON FILE WITH FDA OR THERE IS A MISMATCH BETWEEN THE
MANUFACTURER REGISTRATION NUMBER AND THE MID THAT WAS TRANSMITTED
FOR THE MANUFACTURER. THE PROBLEMS INCLUDED IN THOSE MAJOR REASONS
ARE EXPLAINED FURTHER BELOW.

NOTE: PREVIOUS USE OF A MANUFACTURER REGISTRATION NUMBER DOES NOT
GUARANTEE THAT FUTURE TRANSMISSIONS WILL BE ACCEPTED BY FDA.

THE MOST COMMON "REGISTRATION NOT ON FILE" REJECTS ARE DUE TO:

1. TRANSMISSION OF A REGISTRATION NUMBER THAT WAS CANCELLED BY THE
MANUFACTURER; OR

2. TRANSMISSION OF A REGISTRATION NUMBER THAT HAS BEEN DEACTIVATED
BY FDA DUE TO PROBLEMS CONFIRMING VALIDITY OF THE REGISTRATION
INFORMATION.

THE MOST COMMON MISMATCH REJECTS ARE DUE TO:

1. TRANSMISSION OF THE IMPORTER OR CONSIGNEE REGISTRATION NUMBER
INSTEAD OF THE MANUFACTURER REGISTRATION NUMBER.

2. TRANSMISSION OF THE SHIPPER REGISTRATION NUMBER INSTEAD OF THE
MANUFACTURER REGISTRATION NUMBER; OR

3. TRANSMISSION OF A MANUFACTURER REGISTRATION NUMBER WHERE THE
COUNTRY OF THE MANUFACTURER DOES NOT MATCH THE COUNTRY ASSOCIATED
WITH THE MID USED THE THE TRANSMISSION.

THE REJECT CODES FOR INVALID REGISTRATION APPEAR IN THE BN APPLICATION
BN02 RECORD IN POSITION 65 AND INCLUDE:
(ALSO SEE ADMINISTRATIVE MESSAGE 04-2563 FOR FULL EXPLANATION)

I INVALIDATED BY FDA DUE TO PROBLEMS WITH THE FIRM NAME AND
ADDRESS OR LEGITIMACY OF THE PARTY WHO FILED THE REGISTRATION.
C CANCELLED BY THE FIRM OR THEIR AGENT
F REGISTRATION NOT ON FILE
M MISMATCH IN REGISTRATION

IF YOU RECEIVE A FDA REJECT CODE RELATED TO THE MANUFACTURER'S
REGISTRATION NUMBER, THE APPROPRIATE STEPS MUST BE TAKEN TO VERIFY
THAT THE REGISTRATION NUMBER IS UPDATED AND VALID AND THAT THE CORRECT
CORRESPONDING MID WAS USED IN THE TRANSMISSION. YOU WOULD THEN
TRANSMIT THE VALID REGISTRATION NUMBER IN THE ABI OGA CORRECTION
TRANSACTION COMMONLY KNOWN AS THE 'CP' CORRECTION. IF AFTER MAKING
EVERY EFFORT TO DETERMINE THE CORRECT MANUFACTURER REGISTRATION NUMBER
YOU ARE STILL UNABLE TO DO SO, YOU SHOULD DOCUMENT ALL EFFORTS AND
TRANSMIT THE "FME" A OF C CODE WITH THE MOST ACCURATE "REASON CODE"
LISTED BELOW (REASON CODES K - O) IN THE ABI 'CP' TRANSACTION. IF FDA
DETERMINES THAT DUE DILIGENCE IN OBTAINING THE REGISTRATION NUMBER
WAS NOT EXERCISED, SUBMITTERS MAY BE SUBJECT TO CIVIL MONETARY
PENALTIES AND FINES.

FME QUALIFIER REASON CODES:

K UNABLE TO DETERMINE THE REGISTRATION NUMBER OF THE MANUFACTURER.

L UNABLE TO DETERMINE IDENTITY OF MANUFACTURER - PROVIDING IDENTITY
OF MANUFACTURER'S HEADQUARTERS (IN FDA MID FD01 RECORD POS 48-62).

M UNABLE TO DETERMINE IDENTITY OF MANUFACTURER OR HEADQUARTERS -
PROVIDING INVOICING FIRM'S IDENTITY (IN FDA MID FD01 RECORD
POS 48-62)

O GIFT PACK FOR NON-BUSINESS PURPOSES - PROVIDING SINGLE PRIOR
NOTICE AND IDENTITY OF PACKER (IN FDA MID FD01 RECORD POS 48-62)

IN CASES WHERE THE REGISTRATION NUMBER IS EITHER NOT ON FILE OR
OTHERWISE INVALID, AN AGENT OF THE MANUFACTURER SHOULD CONTACT THE
FURLS REGISTRATION HELP DESK AT 1-800-216-7331 (INSIDE US) OR
1-301-575-0156 (OUTSIDE OF US).