| Title: | FDA DATA REQUIREMENTS: FDA MANUFACTURER AND SHIPPER |
|---|---|
| Date: | 2000-07-28 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS PARTICIPATING IN FDA INTERFACE
FROM: FOOD & DRUG ADMINISTRATION
OFFICE OF REGULATORY AFFAIRS
DIVISION OF IMPORT OPERATIONS AND POLICY
SUBJECT: FDA DATA REQUIREMENTS: FDA MANUFACTURER AND FDA SHIPPER
THE PURPOSE OF THIS MESSAGE IS TO CALL ATTENTION TO A PATTERN OF
DISCREPENCIES AND NON-COMPLIANCE WITH DATA SUPPLIED TO FDA IDENTIFYING
THE MANUFACTURER AND SHIPPER OF FDA REGULATED PRODUCTS.
THE CORRECT AND ACTUAL MANUFACTURER MUST BE PROVIDED TO THE FDA ON
ALL OF THE FOLLOWING PRODUCTS:
ALL HUMAN DRUGS
VETERINARY DRUGS
BIOLOGICS
MEDICAL DEVICES
THIS ALSO APPLIES TO ANY FOOD PRODUCT REQUIRING PROCESS FILING WITH FDA
BEFORE MARKETING IN THE UNITED STATES. ALL OF THESE PRODUCTS REQUIRE
EVIDENCE THEY WERE PRODUCED IN A FACILITY WHICH HAS REGISTERED OR LISTED
ITS PRODUCTS WITH FDA.
SUPPLYING THE CORPORATE HEADQUARTERS, TRADING COMPANY, BROKERAGE OR
OTHER INTERMEDIATE SUPPLIER AS THE MANUFACTURER IS NOT ACCEPTABLE FOR
THESE PRODUCTS. SHIPMENTS IDENTIFIED IN THIS MANNER WILL BE DELAYED
IN PROCESSING AND MAY BE DETAINED UNTIL CORRECT INFORMATION IS PROVIDED.
FURTHER, CONTINUED USE OF INCORRECT FIRM DATA, AS WELL AS OTHER DATA
ERRORS, MAY RESULT IN FILER REMOVAL FROM ELECTRONIC ENTRY CLEARANCE.
PLEASE WORK WITH THE IMPORTER TO CORRECTLY IDENTIFY THIS FIRM DATA
TO FDA. BAD DATA MAY RESULT IN FAILURE TO KEEP VIOLATIVE PRODUCTS OUT OF
UNITED STATES COMMERCE, INCORRECT FIRMS PLACED ON IMPORT DETENTION,
INCREASED SAMPLING AND EXAMS OF AN IMPORTER'S ENTRIES, AND OTHER
ENFORCEMENT ACTIONS.
FDA'S POLICY ON DATA REQUIRED FOR THE "FDA" MANUFACTURER AND SHIPPER
CAN BE REVIEWED AND THE TWO PAGE FORMATTED DOCUMENT CAN BE OBTAINED FROM
THE FOLLOWING INTERNET ADDRESS:
HTTP://WWW.FDA.GOV/ORA/IMPORT/AUTOMATEDSYSTEM.HTML
A COPY OF THIS INFORMATION MAY ALSO BE OBTAINED FROM THE FDA AT
THE FOLLOWING ADDRESS:
FOOD AND DRUG ADMINISTRATION (FDA)
OFFICE OF REGULATORY AFFAIRS
DIVISION OF IMPORT OPERATIONS AND POLICY
5600 FISHERS LANE, HFC-170
ROCKVILLE, MD 20857