1 / 11

FDA - PowerPoint PPT Presentation

  • Uploaded on

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:

I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
Download Presentation

PowerPoint Slideshow about 'FDA' - olesia

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.

- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript


Prior Notice Center


October 2010

San Diego, CA

Fda prior notice center
FDA Prior Notice Center

PNC Director: Anthony C.Taube

Hours of Operation: 24/7/365


  • 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


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.?


    • 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


Prior Notice CenterReceive, Review, Respond

Thank You

Call the PNC at 866-521-2297

Any time of the day / Every day of the year