| Title: | TWO NEW REJECT REASON CODES FOR INVALID REGISTRATION |
|---|---|
| Date: | 2004-12-20 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS
FROM: THE FOOD & DRUG ADMINISTRATION
FDA IS ADDING TWO NEW REJECT REASON CODES FOR INVALID PRIOR NOTICE
REGISTRATION. THESE NEW CODES ARE BEING ADDED TO PROVIDE MORE SPECIFIC
INFORMATION ON WHY THE MANUFACTURER REGISTRATION NUMBER PROVIDED IS
CONSIDERED INVALID AND HAS BEEN REJECTED. USE OF THESE NEW CODES WILL
BEGIN ON JANUARY 20, 2005.
CURRENTLY THE THREE REGISTRATION REJECT REASON CODES INCLUDE:
R = MISSING REGISTRATION
F = REGISTRATION NOT ON FILE
M = MISMATCH IN REGISTRATION
IN THE PAST, FDA WAS SENDING ONLY AN "M" FOR BOTH REGISTRATION NOT ON
FILE AND FOR MISMATCH IN REGISTRATION. IN THE FUTURE "F" WILL BE
RETURNED WHEN THE NUMBER PROVIDED VIA THE PFR AFFIRMATION OF COMPLIANCE
IS NOT AND HAS NEVER BEEN ON FILE AND "M" WHEN THERE IS A MISMATCH
BETWEEN THE REGISTRATION NUMBER AND THE FIRM TRANSMITTED AS THE
MANUFACTURER IN THE FD01 RECORD.
THE TWO NEW REASON CODES TO BE INCLUDED ARE:
I = INVALIDATED THIS MEANS THAT FDA HAS INVALIDATED THE REGISTRATION
DUE TO PROBLEMS WITH THE FIRM NAME AND ADDRESS OR LEGITIMACY OF THE
PARTY WHO FILED THE REGISTRATION.
C = CANCELLED THIS MEANS THE FIRM OR THEIR AGENT HAVE CANCELLED THE
REGISTRATION.
WITH THE ADDITION OF THE TWO NEW REASON CODES THE FOLLOWING IS THE
CURRENT LIST OF FDA REJECT REASON CODES:
THE CODES APPEAR IN THE BN APPLICATION, FD02 RECORD FROM POSITIONS
64 THROUGH 78. NOTE THAT A CODE FOR A GIVEN POSITION MAY VARY.
POSITION CODE DESCRIPTION
64 F FOREIGN CONSIGNEE
65 R, F, M, I, C INVALID REGISTRATION
R = MISSING REGISTRATION
F = REGISTRATION NOT ON FILE
M = MISMATCH IN REGISTRATION
I = INVALIDATED REGISTRATION
C = CANCELLED REGISTRATION
66 Q INVALID QUANTITY
67 M INVALID MID FOR MANUFACTURER
68 S INVALID MID FOR SHIPPER
69 I INVALID IMPORTER FOR FDA
70 C, U INVALID CONSIGNEE FOR FDA
C = INVALID CONSIGNEE
U = UNKNOWN/CONSOLIDATED CONSIGNEE
71 Z INVALID STATE/ZIP FOR US MANUFACTURER
72 O INVALID COUNTRY OF ORIGIN
73 S INVALID COUNTRY OF SHIPPING
74 N OTHER REJECT REASON - CALL FDA
CURRENTLY BEING USED FOR LACK OF BILL
OF LADING(BOL) OR AIRWAY BILL (AWB)
CHECK BEFORE CALLING FDA.
75 P PN DATA REQUIRED (APPLIES TO ENTRY FILERS
ONLY - USE CP TO SEND PN DATA AFTER
REJECT.
76 W WARNING PN DATA NOT REQUIRED (FILER WILL
NOT RECEIVE A CONFIRMATION NUMBER).
77 E INVALID EXEMPTION (FME) QUALIFIER.
78 C, E, X C = INVALID PNC NUMBER
E = EXPIRED PNC NUMBER
X = CANCELLED PNC NUMBER
THE FOOD & DRUG ADMINISTRATION