FDA publishes Guideline Draft on the Registration of Production Sites

In our News from 11 September 2013, we reported about FDA's initiative to identify production sites according to a  uniform system. The identification should be enabled thanks to  a D-U-N-S- (Data Universal Numbering System) number (composed of 9 figures) allocated by the company Dun & Bradstreet.

The topic seems to be crucial for the FDA as it has now released the draft of a "Guidance for Industry" entitled: "Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration". The draft comprises 5 pages including the title page. The actual content (introduction, background, and description of the UFI system) is laid down in one and a half pages. In the end, the only statement of the FDA is that the DUNS number is suitable to the identification of sites. If an alternative identifier shall be used, the FDA should be contacted.

The draft was published on 4 September 2013 and can be commented on within 60 days.

The document can be found here.

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