GMP Training - Merck gets Warning Letter - May 5, 2008

Merck and Company, Inc. received a nine-page Warning Letter from FDA on April 28. In addition to citations for some of their drug products, they were also cited for cGMP deficiencies concerning bulk drug substances and drug components. Areas cited included Production and Process Controls, Failure Investigations, Laboratory Controls, Buildings and Facilities, Maintenance of Equipment, and Containers and Closures. This letter also contains FDA's reaction to Merck's responses to a previous FDA-483, Inspectional Observations, issued previously.

GMP Tip
Warning Letters give us insight into how the FDA thinks and what they are looking for. Use this and other Warning Letters in your GMP training sessions to reinforce the requirement to always follow cGMP and as an example of what could and does occur when FDA finds your company out of compliance.

Read this Warning Letter. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource articles and scroll down.

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