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  1. Inspections, Compliance, Enforcement, and Criminal Investigations

History of Gold Disk

History of Gold Disk

In 1992, FDA provided a service called “FDA on disc” where a subscriber could get a one-year subscription of one CD disc of relevant FDA information each quarter. FDA on disc contained Compliance Programs, 21 CFR, Regulatory Procedures, and commodity specific information. It was very much a product of its time when internet resources were limited. Three years later in 1995, this concept was expanded/repurposed as a tool for FDA investigators and called Gold Disk, so named because of the color of the label affixed to it.

As the internet rose to prevalence and FDA increased the content available, the Gold Disk still found use as a resource investigators could use on laptops when an internet connection was not available. As time progressed, the offline access to FDA documents afforded by the Gold Disk and the effort to maintain up-to-date content on it has become less necessary as investigators can use the FDA website for the information needed for their inspections. In order to continue to support investigators, we’re providing the Inspection References page as a single index of all relevant materials previously found on the Gold Disk in the past.