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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Appendix G Audit Report (Form FDA 3611)

ORA FIELD MANAGEMENT DIRECTIVE No. 76
Appendix G

Subject:
State Contracts-Evaluation of Inspectional Performance
Area:
State Program Management
Date:
1/24/14 Revised

Appendix G
Audit Summary for Other Inspection Programs

 

INTRODUCTION

The Audit Summary for Other Inspection Programs allows the District and the Office of Partnerships to track and document the audits of the egg, medical device, and tissue residue contract inspections, and audits of contract inspections in other programs except food and feed. The performance factors are found in Appendix D, Guidance for Conducting Joint Audit Inspections, Joint Inspections, and Verification Audits for State Auditors. The workbook contains six worksheets labeled as:

  1. Contract Dates
  2. Tracking Sheet
  3. Quarter 1
  4. Quarter 2
  5. Quarter 3
  6. Quarter 4

 

INSTRUCTIONS FOR COMPLETING THE WORKSHEETS

The following instructions are provided for completing the worksheets.

Worksheet 1. Contract Dates

Data entered on this worksheet will populate the Tracking Sheet and the Quarter worksheets.

  1. Enter the name of the FDA reviewer.
  2. Select the District from the drop down list.
  3. Select the State from the drop down list.
  4. Enter the start date of the contract period of performance (MM/DD/YYYY).
  5. Select the Inspection Program from the drop down list.

 

Worksheet 2. Tracking Sheet

Data is not entered on this worksheet. This sheet automatically counts the number of joint audit inspections and joint inspections conducted for the egg, medical device, tissue residue, and other contract programs reported on the quarterly reporting worksheets.

Worksheets 3-6. Audit Records (Quarters 1-4)

Record the number of joint audit inspections and joint inspections on the sheet designated for the quarter. The header is automatically filled with the information entered on worksheet 1.
Column A displays the entry numbers for each sheet.
Data must be entered in columns B-I. The instructions are provided here.

Column B Select the State from the drop down list.
Column C Enter the name of the firm.
Column D Enter the firm FEI/CFN number.
Column E Enter the contract period of performance.
Column F Select the inspection program from the drop down list.
Column G Select the type of audit from the drop down list.
Column H Select yes or no from the drop down list to indicate whether the audit was determined to be acceptable.
Column I Use this space for notes about the audit.
Note: A description of the audit findings must be entered in the Column I for any audits that received a “No” designation in Column H.

 

INSTRUCTIONS FOR NAMING THE WORKBOOK

When naming Appendix G, the following document-naming convention must be used. The standard document name will help distinguish the contents of the workbook simply by name and ensures that the workbook can be located quickly and easily.

The name of the Appendix G contains four elements. The name of the workbook begins with the 3-digit district abbreviation, for example, NYK for New York, followed by the State agency abbreviation, for example, NYSDAM for New York State Department of Agriculture and Markets. The next element of the workbook name is the appendix, which is G. The final element of the workbook name is the beginning year of the contract period of performance.

Here is a sample workbook name showing the four elements explained above.

NYK-NYSDAM-G-2012

If the naming convention is not followed, the workbook will be returned to the District for correction.

INSTRUCTIONS FOR SUBMITTING AUDIT FINDINGS

Quarterly reports are due 10 business days after the end of each quarter of the contract period of performance. Report the number of joint audit inspections and joint inspections on the sheet designated for the quarter. The District must save and email the complete workbook to the OP audit mailbox ContractAudits@fda.hhs.gov