FDA started Initiative for DUNS Numbers of Pharmaceutical Sites

Recommendation
27/28 May 2025
Supervision of the Pharmaceutical Quality System: Challenges and Opportunities
In our News from 4 September 2013, we reported about the DUNS numbers for the identification of pharmaceutical sites in Site Master Files. Usually, this applies only to companies which are located outside the EU/EEA.
Last year, the FDA also started an initiative for the DUNS numbers of companies which have to provide information about the location of their facilities to the FDA. These companies may therefore be contacted by Dun & Bradstreet personnel. According to the FDA there is no legal requirement for companies to collaborate. Nevertheless, the FDA asks for cooperation with the registration.
Please see the FDA's information entitled "Dun and Bradstreet Verification" for the details.
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