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          Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification ProgramsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs
					
		
		January 2018


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2017-N-6908
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Veterinary Medicine
          Center for Food Safety and Applied Nutrition


The purpose of this document is to state the intent of the Food and Drug Administration (FDA, we, or the Agency) not to enforce certain regulatory requirements as they currently apply to certain entities and/or activities.

The applicable requirements are established in our regulations entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (21 CFR part 117); “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (21 CFR part 507); “Standards for Growing, Harvesting, Packing, or Holding of Produce for Human Consumption” (21 CFR Part 112); and “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (21 CFR Part 1, Subpart L).

We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21 CFR 10.115). This guidance is immediately effective because FDA has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)).

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.

Instead, guidances describe the Agency’s 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 Agency guidances means that something is suggested or recommended, but not required.

In this guidance, pronouns such as “you” refer to entities that are covered by this guidance.

**Download the Guidance**

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For questions regarding this document, contact FDA’s FSMA Technical Assistance Network by submitting the inquiry form.


 
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					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-2017-N-6908.

                                                                                  Content current as of:
      01/05/2018
         
                  
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