Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)

Contains Nonbinding Recommendations

February 2012

Additional copies are available from: 

Outreach and Information Center, HFS-009
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
(Tel) 1-888-723-3366

You may submit electronic or written comments regarding this guidance at any time. Submit electronic comments to Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. 

Available in PDF (304KB) only.

Table of Contents

  1. Introduction
  2. Background
  3. Questions and Answers
    1. Who is Subject to the Records Requirements? (Section 1.326)
    2. Who is Excluded From All or Part of the Records Requirements? (Section 1.327)
    3. Definitions (Section 1.328)
    4. Do Other Statutory Provisions and Regulations Apply? (Section 1.329)
    5. Can Existing Records Satisfy the Records Requirements? (Section 1.330)
    6. What Information is Required in the Records You Must Establish and Maintain to Identify the Nontransporter and Transporter Immediate Previous Source and Immediate Subsequent Recipients? (Sections 1.337 and 1.345) 
    7. Who is Required to Establish and Maintain Records for Tracing the Transportation of All Food? (Section 1.351)
    8. What Information is Required in the Transportation Records? (Section 1.352)
    9. What Are the Record Retention Requirements? (Section 1.360) 
    10. What Are the Record Availability Requirements? (Section 1.361) 
    11. What Records Are Excluded From the Records Requirements? (Section 1.362)
    12. What Are the Consequences of Failing to Establish and Maintain Required Records or Make Them Available to FDA? (Section 1.363) 
    13. What Are the Compliance Dates for the Records Requirements? (Section 1.368)

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