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.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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