| Title: | FDA INTERFACE ISSUES |
|---|---|
| Date: | 2000-11-01 |
| To: | abi |
| Links: | previous, next |
TO : ALL ABI BROKERS.
FROM : JOHN OGLIORE
SUBJECT : FDA INTERFACE ISSUES
DATE : 10/31/2000
THERE ARE SEVERAL FDA ISSUES THAT HAVE CAUSED PROBLEMS FOR FILERS
OVER THE PAST FEW MONTHS. THIS ADMINISTRATIVE MESSAGE WILL DISCUSS
SOLUTIONS TO THOSE PROBLEMS.
FOREIGN BASED CONSIGNEE
THIS IS THE MOST FREQUENT CAUSE OF PROBLEMS IN THE FDA INTERFACE.
YOU TO AVOID SEVERE DELAYS IN RELEASE OF YOUR FDA INTERFACE SHIPMENT
THEN DO NOT SEND A FOREIGN BASED (ADDRESS) ENTITY AS THE CONSIGNEE
THIS WILL CAUSE A FDA REJECT IN EVERY CASE. THE FDA INSPECTOR WILL
NOT RECEIVE THE ENTRY TO PROCESS. THE FDA SYSTEM REJECTS IT UP FRONT
WITH A 'DT' REJECT.
SOLUTION. FIND THE CONSIGNEE IN THE UNITED STATES AND SEND THE
IMPORTER NUMBER OR SSN NUMBER FOR THAT ENTITY.
IF YOU DO RECEIVE A 'DT' REJECT THEN YOU MUST TAKE THE FOLLOWING
STEPS:
YOU MUST OBTAIN A FOOD AND DRUG ESTABLISHMENT IDENTIFIER (FEI NUMBER)
THROUGH ABI. THIS IS A TWO PART PROCESS. YOU FIRST SEND THE "ADD
NUMBER" (COMMONLY KNOWN AS THE 'PP' TRANSACTION) TO ABI. ABI WILL
RETURN A 'PT' MESSAGE TELLING YOU THAT THE REQUEST "REQUEST SENT TO
FDA, PROCESS PENDING". WITHIN A FEW MINUTES YOU WILL RECEIVE A SECOND
'PT' MESSAGE WITH A TWELVE DIGIT FEI NUMBER IN THE FDPT-30 RECORD,
POSITIONS 6-17. YOU MUST TAKE THIS NUMBER AND SEND IT IN THE "OTHER"
GOVERNMENT AGENCY CORRECTION" TRANSACTION, COMMONLY KNOWN AS THE '
TRANSACTION, IN THE FD03 RECORD, POSITIONS 15-26. THIS WILL SEND
NEW INFORMATION TO FDA, REMOVE THE REJECT STATUS AND ALLOW FDA TO
PROCESS THE ENTRY.
YOU CAN SAVE YOURSELF APPROXIMATELY FOUR TO SIX HOURS BY SENDING A
U.S. BASED CONSIGNEE IN THE INITIAL TRANSACTION.
SENDING FDA INTERFACE DATA TO ABI
SEVERAL PROBLEMS HAVE SURFACE OVER THE PAST FEW MONTHS THAT
INVOLVE HOW FDA INTERFACE DATA IS SENT TO ABI. TO AVOID THESE
PROBLEMS:
SEND THE FDA DATA IN THE ENTRY SUMMARY TRANSACTION WITH CERTIFICATION
FOR CARGO SELECTIVITY(EXCEPT FOR BORDER 'HN' TRANSACTIONS).
DO NOT SEND THE SAME TRANSACTION TWICE IN A SHORT PERIOD. WE HAVE
FOUND MANY INSTANCES WHERE THE FILER HAS PRESSED THE "SEND" BUTTON
TWICE AND THE TRANSACTION WAS SENT TWICE. THIS WILL ALWAYS CAUSE
PROBLEM IN THE FDA INTERFACE. IF YOU NEED TO SEND THE ENTRY SUMMARY
AGAIN, WAIT FOR THE CARGO SELECTIVITY RESULTS FIRST, THEN RE-SEND
ENTRY SUMMARY WITHOUT THE FDA DATA.
DO NOT SEND AN ENTRY SUMMARY TRANSACTION WITHOUT FDA DATA THEN
IMMEDIATELY SEND THE SAME ENTRY WITH CARGO SELECTIVITY (HI)
TRANSACTION WITH FDA DATA.
UNTIL FURTHER NOTICE, IF YOU NEED TO DELETE A CARGO SELECTIVITY ENTRY
THAT CONTAINS FDA DATA, DO NOT USE THE SAME ENTRY NUMBER. USE A NEW
ENTRY NUMBER.
FDA MANUFACTURER NUMBERS
WHEN SEND A MANUFACTURER UPDATE FOR AN ENTITY WITH A U.S. ADDRESS
NOT SEND A TWO CHARACTER STATE CODE IN THE COUNTRY CODE FIELD. THE
FIELD SHOULD BE SENT WITH 'US'. WE ARE FINDING INSTANCES OF MIDS
WHEN, FOR EXAMPLE, A FILER SENDS "MEMPHIS TN" WHICH TURNS OUT TO BE
"MEMPHIS, TUNISIA" WITH AN ISO CODE OF 'TN' INSTEAD OF 'US'.
ANOTHER PROBLEM OCCURS WHEN A FILER DOES NOT SEND THE PROPERLY
TRANSLATED CITY NAME FOR THE MID CITY. EXAMPLE ARE THE CITY OF
'KOLN' IN GERMANY WHICH PROPERLY TRANSLATED IS 'COLOGNE' AND
'WIEN' WHICH IS AUSTRIAN FOR THE PROPERLY TRANSLATED CITY OF
'VIENNA'
PLEASE CONTACT YOUR CLIENT REPRESENTATIVE IF YOU HAVE ANY QUESTION