Effective Response to FDA 483 is Critical - Jan 14, 2008

After an FDA inspection resulting in the issuance of a Form FDA 483, List of Inspectional Observations, it is CRITICAL to respond to the FDA EFFECTIVELY. If you don’t, it could and often does lead to serious consequences.

Recently a company received a Warning Letter (just before Christmas) because of their inadequate response.

To read this Warning Letter issued to G. Dundas Company, Inc., go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

One issue they were cited for: “You could not provide written training procedures during the inspection and a training record for an employee who has been employed for six months.”

GMP Tip

Lack of written training procedures and training documentation can lead to a Warning Letter. This is so easy to do that it should never be cause for a Warning Letter. But it takes resources and commitment to get it done.

Does your company have the resources necessary for compliance?

Does your company have the commitment to make cGMP compliance a priority?

Does your company invest the time to prepare an effective response to a 483, and then follow through with implementation?

If you answered no to any of these questions, you might want to share this Warning Letter with your management team.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1329 clients since 1996

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