1 / 11

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:

nairi
Download Presentation

FDA

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. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related