Imagine delegating approval authority for a critical quality system function and not writing it down or remembering when you did it. How long would it take the FDA to issue a 483 or WL for lack of documentation? Yet our AG gets a pass on the basic compliance enforcement concept that 'If it's not written down, it didn't happen'. And what about the ever-changing rules and processes at IRS that seems to have targeted certain groups supposedly without management approval? Where are the change control procedures and management responsibility functions exercising oversight? The product was launced without any product or process validation. I never thought I would wish an in-depth FDA audit on anyone...but perhaps some of our government agencies might benefit from the experience. What say you??
Should FDA Oversee IRS and Justice?
Submitted by Anonymous on Sun, 19/05/2013 - 20:12