FDA Message on Rejects of PN Due to Certain Manufacturer Registration Errors
U.S. Customs and Border Protection (CBP) has issued an administrative message from the Food and Drug Administration (FDA) to FDA Prior Notice (PN) filers regarding rejects of PN due to manufacturer registration errors.
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Rejects Commonly Caused by Two Manufacturer Registration Number Errors
The FDA states that there are two main errors associated with manufacturer registration information transmitted using the PFR1 affirmation of compliance (AOC) code and qualifier that will result in the PN submission being rejected. These are:
"Registration not on file" rejects. The most common "registration not on file" rejects are due to:
transmission of a registration number that was cancelled by the manufacturer; or
transmission of a registration number that has been deactivated by FDA due to problems confirming validity of the registration information.
"Mismatch" rejects. FDA states that the most common "mismatch" rejects are due to:
transmission of the importer or consignee registration number instead of the manufacturer registration number;
transmission of the shipper registration number instead of the manufacturer registration number; or
transmission of a manufacturer registration number where the country of the manufacturer does not match the country associated with the manufacturer I.D. (MID) used in the transmission.
Correcting manufacturer registration number errors. If an FDA reject code related to the manufacturer's registration number is received, the appropriate steps must be taken to verify that the registration number is updated and valid and that the correct corresponding MID was used in the transmission. The valid registration number would then be transmitted in the ABI other government agency (OGA) correction transaction (which is commonly known as the 'CP' correction).
If number cannot be determined. If after making every effort to determine the correct manufacturer registration number it is still unknown, all efforts should be documented and the Food Facility Registration Exemption (FME) AOC code should be transmitted with the most accurate "reason code" listed below in the ABI 'CP' transaction:
| K | Unable to determine the registration number of the manufacturer |
| L | Unable to determine identity of manufacturer - providing identity of manufacturer's headquarters (in FDA MID FD01 record, positions 48-62) |
| M | Unable to determine identity of manufacturer or headquarters - providing invoicing firms identity (in FDA MID FD01 record, positions 48-62) |
| O | Gift pack for non-business purposes - providing single PN and identity of packer (in FDA MID FD01 record, positions 48-62) |
The FDA notes that if it determines that due diligence in obtaining the registration was not exercised, submitters may be subject to civil monetary penalties and fines.
In addition, in cases where the registration number is either not on file or otherwise invalid, an agent of the manufacturer should contact the FDA's Unified Registration and Listing System (FURLS) registration help desk at 1-800-216-7331 (inside U.S.) or 1-301-575-0156 (outside of U.S.).
(The FDA notes that previous use of a manufacturer registration number does not guarantee that future transmissions will be accepted by FDA.
In addition, the reject codes for invalid registration appear in the BN application BN02 record in position 65 and include:
| I | Invalidated by FDA due to problems with the firm name and address or legitimacy of the party who filed the registration |
| C | Cancelled by the firm or their agent |
| F | Registration not on file |
| M | Mismatch in registration) |
1 food facility registration number or 'Producer Facility Registration.'
(See ITT's Online Archives or 12/28/04 news, 04122815, for BP summary of Adm: 04-2563 which added reject reason codes "I" and "C," effective January 20, 2005.)
Adm: 05-0312 (dated 03/23/05), which corrects and replaces Adm: 05-0306 (dated 03/22/05), which corrects and replaces Adm: 05-0304 (dated 03/21/05)is available at http://www.brokerpower.com/cgi-bin/adminsearch/admmsg.view.pl?article=2005/2005-0312.ADM
(According to the Adms and CBP sources, Adm: 05-0304 was corrected in order to reflect that reject reason codes appear in the BN02 record (not the FD02 record), and to include the "I" and "C" reject reason codes. CBP sources state that Adm: 05-0306 was corrected for a typographical error. In addition, FDA sources state that the 'R' reject code for invalid registration is currently not being used.)