| Title: | REJECTIONS OF PRIOR NOTICE DUE TO MISMATCH PFR |
|---|---|
| Date: | 2004-11-17 |
| To: | abi |
| Links: | previous, next |
TO: ABI FILERS SUBMITTING PRIOR NOTICE THROUGH ABI
FROM: FOOD AND DRUG ADMINISTRATION
SUBJECT: REJECTIONS OF PRIOR NOTICE DUE TO MISMATCHED/INVALID
REGISTRATION NUMBERS (PFR)
THE FDA PRIOR NOTICE CENTER CONTINUES TO EXPERIENCE AN EXTREMELY HIGH
VOLUME OF CALLS FROM FILERS WHO HAVE SUBMITTED PRIOR NOTICE THROUGH
ABI AND RECEIVED A REJECTION DUE TO AN INVALID OR MISMATCHED
MANUFACTURER'S REGISTRATION IN THE PFR AFFIRMATION OF COMPLIANCE.
BEFORE CONTACTING THE PRIOR NOTICE CENTER FOR THIS TYPE OF REJECTION,
FILERS SHOULD READ AND FOLLOW THE PROCEDURES OUTLINED IN ADMINISTRATIVE
MESSAGE 04-2381. IN PARTICULAR, IF, AFTER A GOOD FAITH EFFORT, A
VALID REGISTRATION NUMBER CANNOT BE OBTAINED FROM THE IMPORTER (OR
OTHER KNOWLEDGEABLE SOURCE) FILERS SHOULD TRANSMIT AN OTHER GOVERNMENT
AGENCY CORRECTION (APPLICATION CP), REPLACING THE PFR AFFIRMATION OF
COMPLIANCE WITH THE FME AFFIRMATION AND A QUALIFIER OF "K" ("K" =
"UNABLE TO DETERMINE THE REGISTRATION NUMBER OF THE MANUFACTURER"). YOU
SHOULD CONTACT YOUR SOFTWARE PROVIDER IF YOU ARE NOT FAMILIAR WITH
THE CORRECTION PROCEDURE. IF REJECTIONS STILL OCCUR, THEN THE PRIOR
NOTICE CENTER CAN BE CONTACTED (24/7) AT 866-521-2297.
FOOD & DRUG ADMINISTRATION