| Title: | FDA REJECTS FOR REGISTRATION NUMBERS |
|---|---|
| Date: | 2004-11-10 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS
FROM: FOOD & DRUG ADMINISTRATION
CUSTOMS & BORDER PROTECTION
SUBJECT: FDA REJECTS FOR INVALID REGISTRATION, MISSING REGISTRATION
AND MISMATCH IN REGISTRATION
THERE HAVE BEEN MANY REJECTS FOR INVALID REGISTRATION (R = MISSING
REGISTRATION, F = REGISTRATION NOT ON FILE, M = MISMATCH IN
REGISTRATION). CURRENTLY FDA IS SENDING AN "M" FOR BOTH REGISTRATION
NOT ON FILE AND FOR MISMATCH IN REGISTRATION.
THESE REJECTS CAN BE CAUSED BY TRANSMISSION OF A ZERO-FILL OR OTHER
"DUMMY" REGISTRATION NUMBER AS THE QUALIFIER TO THE PFR AFFIRMATION OF
COMPLIANCE CODE. DISCONTINUE USE OF ZERO-FILL OR "DUMMY" NUMBERS
IMMEDIATELY.
REJECTS CAN ALSO BE CAUSED BY TRANSMISSION OF MULTIPLE PFR AFFIRMATION
OF COMPLIANCE CODES. THE PFR AND QUALIFIER MUST REPRESENT THE SAME
FIRM TRANSMITTED AS THE MANUFACTURER IN THE FD01 RECORD. DO NOT
TRANSMIT MULTIPLE PFR AFFIRMATIONS OF COMPLIANCE.
IF FILERS RECEIVE A REJECT OF "M" IN POSITION 65 OF THE BN02 RECORD
OUTPUT THEY SHOULD FIRST CHECK TO ENSURE THAT A ZEROES WERE NOT
TRANSMITTED, A "DUMMY" NUMBER WAS NOT USED AND THAT MULTIPLE PFR
AFFIRMATIONS WERE NOT TRANSMITTED. IF NONE OF THESE CONDITIONS APPLY
THEN THE FILER CAN DO THE FOLLOWING:
SUPPLY THE IMPORTER WITH THE RESULTS OF AN ABI MANUFACTURER ID (MID)
QUERY FOR THE MID USED IN THE REJECTED TRANSACTION. HAVE THE IMPORTER
VERIFY THAT THE NAME AND ADDRESS (INCLUDING THE ISO COUNTRY CODE) OF
THE REGISTERED FIRM MATCH THE MID QUERY PROVIDED AND THAT THE
REGISTRATION NUMBER HAS NOT EXPIRED OR BEEN CANCELLED. A COMMON
PROBLEM DISCOVERED IS WHEN ONE OF THE ENTITIES HAS AN ISO CODE OF HK
(HONG KONG) AND THE OTHER CN (CHINA). THE IMPORTER MAY ALSO NEED TO
SUPPLY THE FILER WITH THE CORRECT MANUFACTURER ADDRESS INFORMATION
WHICH WOULD ALLOW THE FILER TO DETERMINE THE CORRECT MID THAT APPLIES.
THE FILER WOULD USE THE ABI MID QUERY AND IF THE MID IS NOT ON FILE
THEN USE THE ABI ADD MANUFACTURER FUNCTION. THE CORRECT INFORMATION
(EITHER THE CORRECT MID OR PFR) WOULD THEN NEED TO BE TRANSMITTED
THROUGH THE 'CP "OTHER GOVERNMENT AGENCY" CORRECTION FUNCTION.
IF AFTER A GOOD FAITH EFFORT, THE MANUFACTURER REGISTRATION NUMBER
CANNOT BE DETERMINED, FILERS CAN TRANSMIT A CP CORRECTION, REMOVING
THE PFR AFFIRMATION AND QUALIFIER AND REPLACING THEM WITH THE
AFFIRMATION OF COMPLIANCE "FME" AND QUALIFIER "K" FOR THE REASON CODE.
REASON CODE "K" = "UNABLE TO DETERMINE THE REGISTRATION NUMBER OF THE
MANUFACTURER).
FOOD & DRUG ADMINISTRATION
CUSTOMS & BORDER PROTECTION
CSMS #04-002414