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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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Presentation Transcript
slide1

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.
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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