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FDA. Prior Notice Center. WESCCON October 2010 San Diego, CA. FDA Prior Notice Center. PNC Director : Anthony C.Taube Hours of Operation: 24/7/365 866-521-2297. Our Mission:

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Fda

FDA

Prior Notice Center

WESCCON

October 2010

San Diego, CA


Fda prior notice center

FDA Prior Notice Center

PNC Director: Anthony C.Taube

Hours of Operation: 24/7/365

866-521-2297

  • Our Mission:

  • Protect the public from a threatened or actual terrorist attackon the US food supply and other related emergencies

  • Prevent food that may be intentionally contaminated with biological, chemical, or radiological agents from entering the US


Objectives

Objectives

After this presentation you will be able to:

  • Explain current & future PN challenges

  • Describe common PN compliance Issues


Current issues challenges

Current Issues/Challenges

  • PN Final Rule in place since May 2009

  • Global challenges & threats

  • FDA and CBP IT systems are in need of updating

  • Until replacement systems are implemented – we need to work together to make current IT systems work

    • Protecting the public health

    • Your role is important!


Future challenges initiatives

Future Challenges/Initiatives

  • New legislation? Additional PN element etc.?

  • ACE/ITDS & FDA MARCS

    • When opportunities arise, provide input for system development

  • CBP & FDA Commissioners met and identified areas of mutual concern.


Pn compliance

PN Compliance


Types of violations

Types of Violations

  • Inadequate Prior Notice

    • No Prior Notice

    • Untimely Prior Notice

    • Inaccurate Prior Notice

  • Unregistered Foreign Food Manufacturer

  • No PN Confirmation Number


Prior notice compliance

Prior Notice Compliance

  • Informed Compliance, PN Refusals, Food Facility Registration shipment holds.

  • PNC has begun making requests for CBP to issue Civil Money Penalties on cases involving repetitive PN violations.

  • FDA Warning Letters, Debarments, Injunctions are also possible.

    • Section 1.284 PN Final Rule

  • Need good info to make good decisions.


Most common pn errors issues

Most Common PN Errors/Issues

September 2010 – NCBFAA RAC Newsletter etc.

  • Ultimate Consignee – FDA needs the “deliver to” address. Completes supply chain for risk assessment.

  • MFR Name & Address Does Not Match Food Facility Registration.

  • Declared MFR is not registered

  • FDA Product Code does not match product description.

  • Failure to file PN for all imported food products.


Pn abi transmission

PN ABI Transmission

  • Required Submitter and Transmitter Information

    • Data Transmission Map

  • Ultimate Consignee

    • FDA Firm Establishment Indicator (FEI) Information

    • What if there is a change in Ultimate Consignee?

      • New PN – Section 1.282 – PN Final Rule


Prior notice center receive review respond

Questions???

Prior Notice CenterReceive, Review, Respond

Thank You

Call the PNC at 866-521-2297

Any time of the day / Every day of the year


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