Monday, June 09, 2008

GMP Tips - FDA Enforcement Shift & Staffing Crisis - June 9, 2008

FLASH! FDA Warning Letters have dropped by half in the past ten years. And recalls have increased.

FLASH! The average age of an FDA staffer is 54, and thirty percent are already eligible for retirement.

And this week FDA is taking heat for the tomato salmonella outbreak (even McDonald's announced today that they will not use sliced tomatoes in their products).

Read more about the Warning Letter decline and the crisis in manpower at FDA. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

How might these issues affect us?
Expect more rigorous inspections. We've already seen longer FDA 483s issued to companies this year.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com

Serving 1433 clients since 1996

Upcoming workshops
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit


Please forward this to others in your organization who may benefit.