+-----------------+-----------------+-----------------------------------+
| **DEPARTMENT OF |                 |                                   |
| HEALTH AND      |                 |                                   |
| HUMAN           |                 |                                   |
| SERVICES**      |                 |                                   |
|                 |                 |                                   |
| **FOOD AND DRUG |                 |                                   |
| A               |                 |                                   |
| DMINISTRATION** |                 |                                   |
|                 |                 |                                   |
| ###             |                 |                                   |
|  CONTRACT AUDIT |                 |                                   |
+-----------------+-----------------+-----------------------------------+
|                 |                 |                                   |
+-----------------+-----------------+-----------------------------------+
| FDA AUDITOR     |                 | STATE INSPECTOR                   |
+-----------------+-----------------+-----------------------------------+
|                 |                 |                                   |
+-----------------+-----------------+-----------------------------------+
| FIRM            |                 | CFN / FEI NUMBER                  |
+-----------------+-----------------+-----------------------------------+
|                 |                 |                                   |
+-----------------+-----------------+-----------------------------------+
| FIRM ADDRESS    |                 |                                   |
+-----------------+-----------------+-----------------------------------+
|                 |                 |                                   |
+-----------------+-----------------+-----------------------------------+
| PRODUCT(S)      |                 |                                   |
| COVERED         |                 |                                   |
+-----------------+-----------------+-----------------------------------+
|                 |                 |                                   |
+-----------------+-----------------+-----------------------------------+
| TIME IN         | TIME OUT        | OVERALL RATING                    |
+-----------------+-----------------+-----------------------------------+
|                 |                 | Acceptable Needs Improvement      |
+-----------------+-----------------+-----------------------------------+
| **I.            |                 |                                   |
| PREINSPECTION   |                 |                                   |
| ASSESSMENT**    |                 |                                   |
+-----------------+-----------------+-----------------------------------+
| 1\. DID THE     |                 |                                   |
| INSPECTOR       |                 |                                   |
| REVIEW THE      |                 |                                   |
| STATE'S         |                 |                                   |
| ESTABLISHMENT   |                 |                                   |
| FILE FOR THE    |                 |                                   |
| PREVIOUS        |                 |                                   |
| INSPECTION      |                 |                                   |
| REPORT AND      |                 |                                   |
| POSSIBLE        |                 |                                   |
| COMPLAINTS OR   |                 |                                   |
| ACCESS\         |                 |                                   |
| OTHER AVAILABLE |                 |                                   |
| RESOURCES IN    |                 |                                   |
| PREPARATION FOR |                 |                                   |
| THE INSPECTION? |                 |                                   |
|                 |                 |                                   |
| > Acceptable    |                 |                                   |
| > Needs         |                 |                                   |
| > Improvement   |                 |                                   |
| >               |                 |                                   |
| > COMMENTS      |                 |                                   |
| > *(required    |                 |                                   |
| > for Needs     |                 |                                   |
| > Improvement)* |                 |                                   |
+-----------------+-----------------+-----------------------------------+
| >               |                 |                                   |
+-----------------+-----------------+-----------------------------------+
| 2\. DID THE     |                 |                                   |
| INSPECTOR HAVE  |                 |                                   |
| THE APPROPRIATE |                 |                                   |
| EQUIPMENT AND   |                 |                                   |
| FORMS TO        |                 |                                   |
| PROPERLY        |                 |                                   |
| CONDUCT THE     |                 |                                   |
| INSPECTION?     |                 |                                   |
|                 |                 |                                   |
| > Acceptable    |                 |                                   |
| > Needs         |                 |                                   |
| > Improvement   |                 |                                   |
| >               |                 |                                   |
| > COMMENTS      |                 |                                   |
| > *(required    |                 |                                   |
| > for Needs     |                 |                                   |
| > Improvement)* |                 |                                   |
+-----------------+-----------------+-----------------------------------+
| >               |                 |                                   |
+-----------------+-----------------+-----------------------------------+
| **II.           |                 |                                   |
| INSPECTION      |                 |                                   |
| OBSERVATIONS    |                 |                                   |
| AND             |                 |                                   |
| PERFORMANCE**   |                 |                                   |
+-----------------+-----------------+-----------------------------------+
| 1\. WAS FDA     |                 |                                   |
| JURISDICTION    |                 |                                   |
| ESTABLISHED?    |                 |                                   |
|                 |                 |                                   |
| > Acceptable    |                 |                                   |
| > Needs         |                 |                                   |
| > Improvement   |                 |                                   |
| >               |                 |                                   |
| > COMMENTS      |                 |                                   |
| > *(required    |                 |                                   |
| > for Needs     |                 |                                   |
| > Improvement)* |                 |                                   |
+-----------------+-----------------+-----------------------------------+
| >               |                 |                                   |
+-----------------+-----------------+-----------------------------------+

+-----------------------------------------------------------------------+
| **II. INSPECTION OBSERVATIONS AND PERFORMANCE *(Continued)***         |
+-----------------------------------------------------------------------+
| 2\. DID THE INSPECTOR SELECT AN APPROPRIATE PRODUCT FOR THE           |
| INSPECTION AND, IF NECESSARY, MAKE APPROPRIATE ADJUSTMENTS BASED ON\  |
| WHAT THE FIRM WAS PRODUCING?                                          |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| 3\. DID THE INSPECTOR ASSESS THE EMPLOYEE PRACTICES CRITICAL TO THE   |
| SAFE PRODUCTION AND STORAGE OF FOOD?                                  |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| 4\. DID THE INSPECTOR PROPERLY EVALUATE THE LIKELIHOOD THAT           |
| CONDITIONS, PRACTICES, COMPONENTS AND/OR LABELING COULD CAUSE THE\    |
| PRODUCT TO BE ADULTERATED OR MISBRANDED?                              |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| 5\. DID THE INSPECTOR RECOGNIZE SIGNIFICANT VIOLATIVE CONDITIONS OR   |
| PRACTICES IF PRESENT AND RECORD FINDINGS CONSISTENT WITH STATE\       |
| PROCEDURES?                                                           |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| **II. INSPECTION OBSERVATIONS AND PERFORMANCE *(Continued)***         |
+-----------------------------------------------------------------------+
| 6\. DID THE INSPECTOR DEMONSTRATE THE ABILITY TO DISTINGUISH BETWEEN  |
| SIGNIFICANT VERSUS INSIGNIFICANT OBSERVATIONS AND ISOLATED\           |
| INCIDENTS VERSUS TRENDS?                                              |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| 7\. DID THE INSPECTOR REVIEW AND EVALUATE THE APPROPRIATE RECORDS AND |
| PROCEDURES FOR THIS ESTABLISHMENT'S OPERATION AND\                    |
| EFFECTIVELY APPLY THE INFORMATION OBTAINED FROM THIS REVIEW?          |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| 8\. DID THE INSPECTOR COLLECT ADEQUATE EVIDENCE AND DOCUMENTATION IN  |
| ACCORDANCE WITH STATE PROCEDURES GIVEN THE NATURE OF THE\             |
| INSPECTIONAL FINDINGS?                                                |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| 9\. DID THE INSPECTOR VERIFY CORRECTION OF DEFICIENCIES IDENTIFIED    |
| DURING THE PREVIOUS STATE INSPECTION?                                 |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| **II. INSPECTION OBSERVATIONS AND PERFORMANCE *(Continued)***         |
+-----------------------------------------------------------------------+
| 10\. DID THE INSPECTOR ACT IN A PROFESSIONAL MANNER AND DEMONSTRATE   |
| PROPER SANITARY PRACTICES DURING THE INSPECTION?                      |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| **II. A. INSPECTION OBSERVATIONS AND PERFORMANCE FOR                  |
| 'HACCP-REGULATED' FACILITIES**                                        |
+-----------------------------------------------------------------------+
| > **Note to Auditor:** These four questions apply to only firms       |
| > subject to HACCP regulations. These four questions should be left\  |
| > blank for firms not subject to HACCP regulations.                   |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
| 1\. DID THE INSPECTOR USE THE \"FISH AND FISHER PRODUCTS HAZARDS AND  |
| CONTROLS GUIDE\" OR THE \"JUICE HACCP HAZARDS AND CONTROLS GUIDE,\"   |
| AS APPROPRIATE, TO IDENTIFY AND EVALUATE THE HAZARDS ASSOCIATED WITH  |
| THE PRODUCT AND PROCESS?                                              |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| 2\. DID THE INSPECTOR ASSESS THE FIRM'S IMPLEMENTATION OF SANITATION  |
| MONITORING FOR THE APPLICABLE EIGHT KEY AREAS OF SANITATION?          |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| 3\. DID THE INSPECTOR REVIEW THE FIRM'S HACCP PLAN (OR NECESSARY      |
| PROCESS CONTROLS IN THE ABSENCE OF A HACCP PLAN) AND APPLICABLE       |
| MONITORING, VERIFICATION AND CORRECTIVE ACTION RECORDS, INCLUDING     |
| THOSE RELATED TO SANITATION?                                          |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| **II. A. INSPECTION OBSERVATIONS AND PERFORMANCE FOR                  |
| 'HACCP-REGULATED' FACILITIES *(Continued)***                          |
+-----------------------------------------------------------------------+
| 4\. DID THE INSPECTOR RECOGNIZED EFICIENCIES IN THE FIRM'S MONITORING |
| AND SANITATION PROCEDURES THROUGH IN-PLANT OBSERVATIONS?              |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| **III. ORAL AND WRITTEN COMMUNICATION**                               |
+-----------------------------------------------------------------------+
| 1\. DID THE INSPECTOR IDENTIFY HIMSELF/HERSELF AND MAKE APPROPRIATE   |
| INTRODUCTIONS, WHICH INCLUDE EXPLAINING THE PURPOSE AND SCOPE OF THE  |
| INSPECTION?                                                           |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| 2\. DID THE INSPECTOR USE SUITABLE INTERVIEWING TECHNIQUES?           |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+
| 3\. DID THE INSPECTOR EXPLAIN FINDINGS CLEARLY AND ADEQUATELY         |
| THROUGHOUT THE INSPECTION?                                            |
|                                                                       |
| > Acceptable Needs Improvement                                        |
| >                                                                     |
| > COMMENTS *(required for Needs Improvement)*                         |
+-----------------------------------------------------------------------+
| >                                                                     |
+-----------------------------------------------------------------------+

+---------------------------------------------------------+------------+
| **III. ORAL AND WRITTEN COMMUNICATION *(Continued*)**   |            |
+---------------------------------------------------------+------------+
| 4\. DID THE INSPECTOR ALERT THE FIRM'S APPROPRIATE      |            |
| MANAGEMENT WHEN AN IMMEDIATE CORRECTIVE ACTION WAS      |            |
| NECESSARY?                                              |            |
|                                                         |            |
| > Acceptable Needs Improvement                          |            |
| >                                                       |            |
| > COMMENTS *(required for Needs Improvement)*           |            |
+---------------------------------------------------------+------------+
| >                                                       |            |
+---------------------------------------------------------+------------+
| 5\. DID THE INSPECTOR ANSWER QUESTIONS AND PROVIDE      |            |
| INFORMATION IN AN APPROPRIATE MANNER?                   |            |
|                                                         |            |
| > Acceptable Needs Improvement                          |            |
| >                                                       |            |
| > COMMENTS *(required for Needs Improvement)*           |            |
+---------------------------------------------------------+------------+
| >                                                       |            |
+---------------------------------------------------------+------------+
| 6\. DID THE INSPECTOR WRITE THEIR FINDINGS ACCURATELY,  |            |
| CLEARLY AND CONCISELY ON THE STATE FORM/DOCUMENT LEFT   |            |
| WITH THE FIRM?                                          |            |
|                                                         |            |
| > Acceptable Needs Improvement                          |            |
| >                                                       |            |
| > COMMENTS *(required for Needs Improvement)*           |            |
+---------------------------------------------------------+------------+
| >                                                       |            |
+---------------------------------------------------------+------------+
|                                                         |            |
+---------------------------------------------------------+------------+
|                                                         |            |
+---------------------------------------------------------+------------+
| > NOTE: EVERY ITEM MARKED \"NEEDS IMPROVEMENT\" MUST BE |            |
| > ACCOMPANIED BY AN EXPLANATION OF WHY THE ITEM WAS     |            |
| > JUDGED AS NEEDING IMPROVEMENT.                        |            |
| >                                                       |            |
| > **Overall Rating:**                                   |            |
| >                                                       |            |
| > If three or less items are marked \"needs             |            |
| > improvement,\" the overall rating is \"acceptable.\"  |            |
| > If four or more items are marked \"needs              |            |
| > improvement,\" the overall rating is \"needs          |            |
| > improvement.\" The overall rating must be marked in   |            |
| > the space provided in the header on the first page.   |            |
| >                                                       |            |
| > All questions must be answered \"acceptable\" or      |            |
| > \"needs improvement,\" except for section I*I.A.      |            |
| > Inspection Observations and Performance for           |            |
| > 'HACCP-Regulated' firms*. **If the establishment is   |            |
| > not subject to Seafood or Juice HACCP regulations,    |            |
| > leave the scoring for these four questions blank.**   |            |
| >                                                       |            |
| > If four or more evaluated items are marked as \"needs |            |
| > improvement,\" the state program manager must be      |            |
| > notified by the appropriate FDA liaison that          |            |
| > additional training or other performance improvement  |            |
| > measures for then inspector being audited should be   |            |
| > initiated. All contract inspectors who receive an     |            |
| > overall audit score of \"needs improvement\" shall    |            |
| > receive remedial training in deficient areas or as    |            |
| > agreed upon by the FDA Project and Co-Project         |            |
| > Officers prior to resuming contract inspection        |            |
| > duties.                                               |            |
+---------------------------------------------------------+------------+
|                                                         |            |
+---------------------------------------------------------+------------+
|                                                         |            |
+---------------------------------------------------------+------------+
| **7ADDITIONAL COMMENTS**                                |            |
+---------------------------------------------------------+------------+
| >                                                       |            |
+---------------------------------------------------------+------------+
|                                                         |            |
+---------------------------------------------------------+------------+
| SIGNATURE OF FDA AUDITOR                                | DATE       |
+---------------------------------------------------------+------------+
|                                                         |            |
+---------------------------------------------------------+------------+