Warning Letters due to Inadequate Response to FDA 483s Rising - Mar 17, 2008

The number of Warning Letters issued because of an Inadequate Response to a FDA 483 continues to grow. One interesting Warning Letter, issued recently to Vintage Pharmaceuticals, LLC, points out the importance of good recordkeeping.

Read this letter. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Tip
Use Warning Letters like this one in your GMP training sessions to reinforce the importance of following cGMP as well as the requirement to follow procedures and document what is done when it's done.

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