Title III Fact Sheet

F.D.A. Legislation-Registration-Compliancy Deadlines Fact Sheet

F.D.A. Legislation-Registration-Compliancy Deadlines Fact Sheet

The Bio-terrorism Preparedness Act of 2002 (Article III) has implemented its final ruling, which requires the maintenance of records by persons who manufacture, process, pack, distribute, receive, or import food in, or to the U.S. This Act covers all aspect of ingredient and batch tracking/traceability.

Records must allow for the identification of previous sources and subsequent recipients of food. Persons covered by the regulation who employ 500 or more full-time employees (FTEs) had to be in compliance by December 9, 2005, and those who employ 11 to 499 FTEs- June 9, 2006; 10 or fewer FTEs- December 11, 2006. http://www.fda.gov/Food/FoodDefense/Bioterrorism/Recordkeeping/ucm061619.htm Records must be made available to the FDA within 4 hrs. between 8:00am-6:00pm Mon.-Fri., or 8 hrs. any other time.

Registration: 21 CFR Parts 1 and 20
The FDA’s final regulation requires domestic and foreign facilities that manufacture, pack, or hold food for human or animal consumption in the U.S. to register by Dec. 12, 2003.

To Register 24/7, Go To: FDA Compliance Regulatory Registration Information

In Summary:

  1. December 11, 2006 – Final date for All to be Compliant.
  2. FDA availability: 4 hrs. Mon. through Fri. (8am-6pm), 8 hrs.- other.
  3. Require registration by December 12, 2003- We urge companies to please register today to enable the FDA to Act!

Solution: We Will Protect You And You Will Protect Us!

Matrix’s systems are designed to manage All Aspects of FDA Reporting, recipe management, lot integration, transportation Traceability or Tracking, warehouse operations, and at all levels.

Please contact Matrix Controls with any questions, or feel free to fill out a Needs Analysis Form , where we can further provide solutions for your company.