Free 3610 - Federal

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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

CONTRACT AUDIT
FDA AUDITOR STATE INSPECTOR

FIRM

CFN / FEI NUMBER

FIRM ADDRESS

PRODUCT(S) COVERED

DATE

TIME IN

TIME OUT

OVERALL RATING

Acceptable I.
1.

Needs Improvement

PREINSPECTION ASSESSMENT
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.
1. WAS FDA JURISDICTION ESTABLISHED?

INSPECTION OBSERVATIONS AND PERFORMANCE

Acceptable

Needs Improvement

COMMENTS (required for Needs Improvement)

FORM FDA 3610 (10/03) PAGE 1 OF 7

PSC Media Arts (301) 443-1090

EF

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II.
2.

INSPECTION OBSERVATIONS AND PERFORMANCE (Continued)
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)

FORM FDA 3610 (10/03) PAGE 2 OF 7

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II.
6.

INSPECTION OBSERVATIONS AND PERFORMANCE (Continued)
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)

FORM FDA 3610 (10/03) PAGE 3 OF 7

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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)

FORM FDA 3610 (10/03) PAGE 4 OF 7

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II.A.
4.

INSPECTION OBSERVATIONS AND PERFORMANCE FOR 'HACCP-REGULATED' FACILITIES (Continued)

DID THE INSPECTOR RECOGNIZE DEFICIENCIES IN THE FIRM'S MONITORING AND SANITATION PROCEDURES THROUGH IN-PLANT OBSERVATIONS?

Acceptable

Needs Improvement

COMMENTS (required for Needs Improvement)

III.
1.

ORAL AND WRITTEN COMMUNICATION
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)

FORM FDA 3610 (10/03) PAGE 5 OF 7

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III.
4.

ORAL AND WRITTEN COMMUNICATION (Continued)
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 WHY THE ITEM WAS JUDGED AS NEEDING IMPROVEMENT.

BY AN EXPLANATION OF

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 II.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 the 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.
FORM FDA 3610 (10/03) PAGE 6 OF 7

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ADDITIONAL COMMENTS

SIGNATURE OF FDA AUDITOR

DATE

FORM FDA 3610 (10/03) PAGE 7 OF 7