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Listing of Significantly Regulated Organizations (SRO)

Which companies are included on the SRO List?

A publicly traded company, US or foreign stock exchange, is added to the SRO List if it meets either of the following criteria:

  • It is an organization for which the sales of products regulated by the Food and Drug Administration (FDA) constitute ten percent or more of annual gross sales in the organization's previous fiscal year;
  • An organization that does not have a record of sales of FDA-regulated products will be deemed to be significantly regulated if its operations are predominately in fields regulated by FDA, or if its research, development, or other business activities are reasonably expected to result in the development of products that are regulated by FDA.

For a monthly listing of all added and removed Significantly Regulated Organizations please click the following link: Monthly Added & Removed Significantly Regulated Organizations (SRO)

For the entire SRO list in a searchable format, please click the following link: https://www.accessdata.fda.gov/scripts/SDA/sdNavigation.cfm?sd=srolist&previewMode=true. You can search the list by entering the DUNS NUMBER, BUSINESS NAME, or TICKER SYMBOL in the search criteria.