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          Release of ORA Laboratory Analytical Results to the Responsible PartySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Release of ORA Laboratory Analytical Results to the Responsible Party
					Guidance for Food and Drug Administration Staff
		
		March 2019


	Download the  Final Guidance Document 

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    PrintDocket Number:
		    FDA-2019-D-1163
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition
          Center for Veterinary Medicine
          Office of Regulatory Affairs
          Center for Tobacco Products
          Center for Devices and Radiological Health


This document provides guidance for FDA staff regarding the release of final and, in some circumstances, preliminary Office of Regulatory Affairs (ORA) laboratory analytical results to the responsible party. This policy applies to samples collected during FDA regulatory activities and analyzed in ORA laboratories.  It applies to FDA personnel assigned to deliver and discuss ORA laboratory analytical results with the responsible party. The policy does not require the responsible party to file a Freedom of Information Act (FOIA) request for the records.


 
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						All written comments should be identified with this document's docket number: FDA-2019-D-1163.

                                                                                  Content current as of:
      03/01/2019
         
                  
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