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          Guidance for Industry: Exempt Infant Formula ProductionSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Guidance for Industry: Exempt Infant Formula Production
					
		
		April 2016


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2014-D-0044
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


*Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports*

This guidance is intended to convey to industry the current thinking of the Food and Drug Administration (FDA or we) about the manufacturing of exempt infant formulas in relation to the requirements for current good manufacturing practices (CGMPs), quality control procedures, conduct of audits, and records and reports for nonexempt infant formulas in 21 CFR part 106.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word *should*in our guidances means that something is suggested or recommended, but not required.

**Download the Guidance**

Related Information

More Infant Formula Guidance Documents & Regulatory InformationSubmit Comments
	   		  			    		Submit Comments Online
					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2014-D-0044.

                                                                                  Content current as of:
      04/15/2016
         
                  
Regulated Product(s)
		 Food & Beverages
			  			     			  						              
			
			
			
			
			
						  Infant Formula & FoodsSearch for FDA Guidance Documents

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