GE Consent Decree Letter to Customers

In January 2007 GE sent a letter to customers regarding recent FDA enforcement actions resulting in a stop shipment and Consent Decree. The letter is at the link provided. Some of the issues leading to this relatd to recalls in which software was part fo the cause or corrective action. GE announcements on this are posted on our recall page along with the initial FDA recall notifications.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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