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FDA

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

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  1. FDA Prior Notice Center WESCCON October 2010 San Diego, CA

  2. 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

  3. Objectives After this presentation you will be able to: • Explain current & future PN challenges • Describe common PN compliance Issues

  4. 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!

  5. 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.

  6. PN Compliance

  7. Types of Violations • Inadequate Prior Notice • No Prior Notice • Untimely Prior Notice • Inaccurate Prior Notice • Unregistered Foreign Food Manufacturer • No PN Confirmation Number

  8. 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.

  9. 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.

  10. 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

  11. 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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