| Title: | "M" MISMATCH PRIOR NOTICE FDA REJECTS |
|---|---|
| Date: | 2005-07-19 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS
FROM: CLIENT REPRESENTATIVE BRANCH
FOOD & DRUG ADMINISTRATION
SUBJECT: "M" MISMATCH PRIOR NOTICE FDA REJECTS
EVERY WEEK HUNDREDS OF FDA PRIOR NOTICE LINES ARE REJECTED THROUGH
THE 'BN' TRANSACTION WITH THE REASON CODE "M" WHICH STANDS FOR
"MISMATCH IN REGISTRATION". THE "MATCH" THAT FDA DOES IS BETWEEN THE
NAME AND ADDRESS IN THE PRIOR NOTICE AFFIRMATION OF COMPLIANCE 'PFR'
FOOD FACILITY REGISTRATION NUMBER AND THE MID (MANUFACTURER'S ID)
SUPPLIED IN THE ENTRY. A REVIEW OF THESE REJECTS SHOWS THE MAIN
PROBLEM IS WITH THE CREATION OF AND CONTINUED USE OF IMPROPERLY
CONSTRUCTED MID'S ESPECIALLY IN REGARDS TO THE ISO COUNTRY CODE.
THE FOLLOWING COUNTRY CODES ARE RESPONSIBLE FOR 90% OF THE PROBLEMS:
1. AUSTRALIA IS 'AU', AUSTRIA IS 'AT'
2. SAUDIA ARABIA IS 'SA', SOUTH AFRICA IS 'ZA'
3. BELGIUM IS 'BE', BULGARIA IS 'BG'
4. SWITZERLAND IS 'CH' NOT ANY CODE BEGINNING WITH 'S'
5. KENYA IS 'KE', KOREA IS 'KR'
6. SRI LANKA IS 'LK', SIERRA LEONE IS 'SL'
7. SINGAPORE IS 'SG', SLOVENIA IS 'SI' SENEGAL IS 'SN'
8. THE "I" COUNTRIES ARE WHERE MOST ERRORS ARE MADE:
ID = INDONESIA
IE = IRELAND
IL = ISRAEL
IN = INDIA
IQ = IRAQ
IR = IRAN
IS = ICELAND
IT = ITALY
9. ANOTHER SIGNIFICANT PROBLEM AREA IS THE USE OF ISO CODES FOR
UNITED STATES BASED MANUFACTURERS WHEN THE ISO CODE IS THE SAME
AS THE US POSTAL CODE FOR THE STATE. EXAMPLES:
LITTLE ROCK, ARGENTINA
MOBILE, ALBANIA
DENVER, COLOMBIA
CHICAGO, ISRAEL
NEW ORLEANS, LAOS
MINNEAPOLIS, MONGOLIA
THE ISO CODES THAT SHOULD NEVER BE SENT FOR US ADDRESSES THAT MATCH
US POSTAL CODES (ONLY 'US' SHOULD BE USED) ARE:
AR, AL, AZ, CO, DE, GA, ID, IL, IN, KE, LA, MA, MD, MN, MO, MS, MT
NC, NE, PA, SD, SC, TN, VA
PLEASE CONTACT YOUR ASSIGNED CLIENT REPRESENTATIVE IF YOU HAVE
ANY QUESTIONS.
CLIENT REPRESENTATIVE BRANCH
FOOD & DRUG ADMINISTRATION
CSMS #05-000975