Warning Letter Roundup – January 2017

By Deb Bartel, 12th January 2017

The FDA sends Warning Letters and 483s to companies who significantly violate FDA regulations. We gather those related to computer system issues so that you can help ensure your organization doesn’t fail an inspection for similar violations. Organizations who received warning letters citing computer system issues: Wockhardt This Warning Letter cites the failure to validate 12 systems. Download this warning letter. Zyno  … Read more

Warning Letter Roundup – December 2016

By Deb Bartel, 19th December 2016

The FDA sends Warning Letters and 483s to companies that significantly violate FDA regulations. We gather those related to computer system issues so that you can help ensure your organization doesn’t fail an inspection for similar violations. Organizations who received warning letters citing computer system issues: F.P. Rubinstein Y Cia This Warning Letter contains many observations impacting software quality, including  … Read more