| Title: | FDA PRIOR NOTICE ISSUES |
|---|---|
| Date: | 2005-05-27 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS AND ABI SOFTWARE VENDORS
FROM: CBP CLIENT REPRESENTATIVE BRANCH
FOOD & DRUG ADMINISTRATION
SUBJECT: RECENT FOOD & DRUG PRIOR NOTICE REJECTS
REFERENCE: ADMINS: 03-2619, 03-2625, 04-1779, 04-2355, 04-2525
05-0019, 05-0110, 05-0216, 05-0312
ALL ABI FILERS WHO FILE FDA PRIOR NOTICE ENTRIES AND ESPECIALLY SOFTWARE
SUPPLIERS SHOULD REVIEW THE REFERENCED ADMINISTRATIVE MESSAGES ABOVE.
THE FOLLOWING REJECT ISSUES HAVE CAUSED SIGNIFICANT PROBLEMS IN
RELEASE OF BTA REGULATED SHIPMENTS DUE PRIMARILY TO PROGRAMMING
DEFICIENCIES:
1. USE OF AFFIRMATIONS OF COMPLIANCE OTHER THAN 'SLN', 'PNC' OR 'PND
IN THE FIRST AFFIRMATION OF COMPLIANCE BLOCK IN THE FD01 RECORD,
POSITIONS 20-22. NO OTHER AFFIRMATION CODES CAN BE USED IF THE ENTRY
IS A PRIOR NOTICE ENTRY. SOFTWARE SUPPLIERS SHOULD INSURE THAT PROPER
EDITS ARE IN PLACE TO REJECT ANY OTHER AFFIRMATIONS (E.G. 'PFR').
2. LACK OF A 'BOL' OR 'AWB' AFFIRMATION RESULTING IN A 'N' REJECT IN
THE 'BN' APPLICATION. SOFTWARE SUPPLIERS SHOULD ENSURE THAT EDITS ARE
IN PLACE TO REQUIRE EITHER ONE OF THE ABOVE AFFIRMATIONS BEFORE THE
ENTRY IS TRANSMITTED.
3. THE 'M' REGISTRATION REJECT. FILERS MUST CHECK THAT THE FDA
MANUFACTUER CODE (MID) MATCHES THE MANUFACTURER SENT IN THE 'PFR'
AFFIRMATION OF COMPLIANCE CODE. YOU CANNOT SEND, FOR EXAMPLE, A MID
THAT BEGINS WITH THE ISO CODE 'CN' AND A PFR WHO FDA HAS ON FILE AS
LOCATED IN SINGAPORE.
4. SENDING A FOREIGN BASED CONSIGNEE. THIS IS COVERED IS MANY OF THE
REFERENCED ADMINISTRATIVE MESSAGES ESPECIALLY 04-2525. IF A FOREIGN
CONSIGNEE IS SENT IN A FDA OR BTA ENTRY IT IS AN AUTOMATIC REJECT.
SOFTWARE SUPPLIERS SHOULD HAVE AN EDIT THAT REJECTS ANY ATTEMPT TO SEND
A FOREIGN ADDRESS IN THE CONSIGNEE RECORD.
IF YOU HAVE ANY QUESTIONS PLEASE CONTACT YOUR ASSIGNED CLIENT
REPRESENTATIVE.
PREPARED BY: JOHN OGLIORE, CLIENT REPRESENTATIVE (206) 553-5228