| Title: | FDA EDITS IN ABI - MAY 13, 2004 - FDA REGISTRATION NBR |
|---|---|
| Date: | 2004-05-04 |
| To: | abi |
| Links: | previous, next |
YOUR ATTENTION IS DIRECTED TO ADMINISTRATIVE MESSAGE 04-0982 DATED APRIL
19, 2004 WHICH PROVIDED A REMINDER AND ADDITIONAL INFORMATION REGARDING
FULL ABI EDITS FOR FDA PRIOR NOTICE EFFECTIVE MAY 13, 2004.
PLEASE BE ADVISED THAT THE FDA REGISTRATION NUMBER IS NOT A MANDATORY
DATA ELEMENT AT THIS TIME.
IF A MANUFACTURER OR SHIPPER IS EXEMPT FROM REGISTRATION, THE FDA DATA
SHOULD INCLUDE THE AFFIRMATION OF COMPLIANCE CODE 'FME' (MANUFACTURER)
OR 'FSE' (SHIPPER) WITH A QUALIFIER OF 'Y'. IF NOT EXEMPT, THESE
AFFIRMATIONS OF COMPLIANCE SHOULD BE PROVIDED WITH A QUALIFIER OF 'N'. IF
IF NOT EXEMPT, AND A REGISTRATION NUMBER HAS BEEN ISSUED TO THE
MANUFACTURER, PROCESSOR, OR SHIPPER AS APPROPRIATE, THE AFFIRMATION OF
COMPLIANCE INDICATOR 'PFR' (MANUFACTURER OR PROCESSOR) OR 'SFR'
(SHIPPER) AND THE APPROPRIATE REGISTRATION NUBER AS QUALIFIER
SHOULD BE GIVEN.
IF A REGISTRATION NUMBER HAS NOT YET BEEN ISSUED TO A FACILITY, OR IF
THE FACILITY HAS NOT YET REGISTERED, DO NOT SEND EITHER OF THE 'PFR' OR
'SFR' AFFIRMATION CODES.
ABI WILL ONLY REJECT IF REGISTRATION NUMBER DATA IS PROVIDED AND IS
INCORRECT IN FORMAT. THE USE OF THE 'PFR' OR 'SFR' AFFIRMATION CODES
WITHOUT ANY ASSOCIATED REGISTRATION NUMBER AS THE QUALIFIER IS
CONSIDERED AN INCORRECT FORMAT AND WILL BE CAUSE FOR AN ABI REJECTION.
THE ABSENCE OF REGISTRATION NUMBER DATA WILL NOT BE CAUSE FOR AN ABI
REJECT AT THIS TIME.
QUESTIONS SHOULD BE DIRECTED TO YOUR CLIENT REPRESENTATIVE.