U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Inspection References
  4. Field Management Directives
  5. Appendix B.2 Data Reporting Instructions for Food Contract Audits
  1. Field Management Directives

Appendix B.2 Data Reporting Instructions for Food Contract Audits

ORA FIELD MANAGEMENT DIRECTIVE No. 76
Appendix B.2

Subject:
State Contracts-Evaluation of Inspectional Performance
Area:
State Program Management
Date:
1/23/14 Revised
 

Printer Friendly Version: PDF Size 37kb

Audits of contract inspections are reported as investigation operations, operation code 13. The PAC for food contract audits is 03R843

  1. Select Investigation Operation
  2. Select Stand Alone Investigation
  3. At the Maintain Investigations screen, data must be entered in the fields listed here.
    • Accomplishing District
    • Start Date
    • Investigation Basis – select Surveillance
    • PAC – select 03R843
    • Reason for Investigation – enter the applicable descriptions listed here:

      For general food sanitation inspections:

      Food Sanitation Contract Audit
      Food Sanitation Training Audit
      Food Sanitation Verification Audit

      For LACF or acidified food inspections:

      LACF Contract Audit
      LACF Training Audit
      LACF Verification Audit

      For seafood HACCP inspections:

      Seafood HACCP Contract Audit
      Seafood HACCP Training Audit
      Seafood HACCP Verification Audit

      For juice HACCP inspections:

      Juice HACCP Contract Audit
      Juice HACCP Training Audit
      Juice HACCP Verification Audit

NOTE: The instructions above do not apply to joint inspections conducted for purposes other than auditing a contract inspection. Joint inspections conducted for purposes other than auditing, such as compliance/enforcement and training should continue to be reported as an inspection under operation code 12, and against the appropriate PAC and compliance program. Only one coversheet should be prepared per inspection with both FDA and state time recorded for joint inspection purposes.

Reporting Instructions for States in Phase II and III

Only the State inspector, not the State auditor, will report his/her time in eSAF. The number of hours will be reported as an audit not an inspection. At the time data is entered into eSAF, the State data entry user will change the Inspection Type field on the Add/Update Inspection Operation screen from "State" to "Audit". In Phase II, the FDA investigator will report time following the instructions in the Appendix B.2

 
Back to Top