FDA Enforcement Report

FDA issues a weekly Enforcement Report. This document contains very useful information that we can use in our GMP Training sessions. For instance, in the February 1, 2006 Enforcement Report, some of the reasons for product recalls include:

• Contamination
• Mislabeling
• Lack of validation
• Short fill volumes
• Illegible lot numbers and expiration dates
• Incorrect lot numbers and expiration dates
• Incorrect components in the package

Training Tip

Print the FDA Enforcement Report and make copies for those participating in GMP training sessions. Have them list all of the reasons for product recalls and discuss what procedures you have in place to prevent these things from occurring at your company. Then stress the importance of following those procedures. Conduct a discussion of all the costs associated with these product failures and recalls.

Key learning point: Prevention is the key to success.

You can download FDA's February 1 Enforcement Report here
www.GMPTrainingSystems.com/asp/resources.asp
Scroll down to FDA Resources

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