FDA 3610 Field Inspection Audit 2023

OMB Number: 0910-0909 Exp Date: XX/XX/XXXX
See bottom of page 9 for PRA statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG
ADMINISTRATION FIELD INSPECTION AUDIT
AUDITOR

STATE INSPECTOR

FIRM NAME

FEI NUMBER

FIRM ADDRESS
PRODUCT(S) COVERED
TIME IN

DATE
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
II. INSPECTION
OBSERVATIONS
AND
PERFORMANCE
1. Was FDA jurisdiction established?

☐ Acceptable ☐ Needs Improvement
COMMENTS (required for Needs Improvement)

FORM FDA 3610 (03/2020)

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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)

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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)

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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. INSPECTIONAL OBSERVATIONS AND PERFORMANCE FOR “HACCP-REGULATED” FACILITIES
Note to Auditor: These four questions only apply to 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 Fishery 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 HAACP 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 (03/2020)

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II.A. INSPECTIONAL OBSERVATIONS AND PERFORMANCE FOR “HACCP-REGULATED” FACILITIES
4. 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. 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)

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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 document/form left

with the firm?

☐ Acceptable ☐ Needs Improvement
COMMENTS (required for Needs Improvement)

FORM FDA 3610 (03/2020)

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IV. INSPECTIONAL OBSERVATIONS AND PERFORMANCE
FOR PC LIMITED SCOPE AND MODIFIED SCOPE AUDITS
1. Did the inspector properly evaluate the good manufacturing requirements (117 Subparts A, B, and F, or

equivalent state regulation)? This question applies to all audits performed including food, seafood and
juice. It cannot be left blank.

☐ Acceptable ☐ Needs Improvement
COMMENTS (required for Needs Improvement)

2. Did the inspector conduct a broad-based assessment of the preventative controls program where

necessary? This question applies to limited scope PC inspections or if it is a qualified facility that
attested under 21 CFR 117.201(a)(2)(i). If the question does not apply, select Not Applicable.

☐ Acceptable ☐ Needs Improvement ☐ Not Applicable
COMMENTS (required for Needs Improvement)

3. Did the inspector evaluate if the facility was in compliance with its attestation? Only applies when a firm

self-attests under 21 CFR 117.201(a)(2)(i) or (ii). If the question does not apply, select Not Applicable.

☐ Acceptable ☐ Needs Improvement ☐ Not Applicable
COMMENTS (required for Needs Improvement)

4. Did the inspector properly evaluate the implementation of time/temperature controls? Only answer if the

facility is a warehouse solely engaged in the storage of unexposed packaged food that requires
refrigeration for safety. If the question does not apply, select Not Applicable.

☐ Acceptable ☐ Needs Improvement ☐ Not Applicable
COMMENTS (required for Needs Improvement)

FORM FDA 3610 (03/2020)

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ADDITIONAL COMMENTS

SIGNATURE OF AUDITOR

FORM FDA 3610 (03/2020)

DATE

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NOTE: EVERY ITEM MARKED "NEEDS IMPROVEMENT" MUST BE ACCOMPANIED BY AN EXPLANATION OF
WHY THE ITEM WAS MARKED AS NEEDING IMPROVEMENT.
Special Instructions:
Section II.A. INSPECTIONAL OBSERVATIONS AND PERFORMANCE FOR “HACCP-REGULATED” FACILITIES
• Answer this section if the establishment is subject to Seafood or Juice HACCP regulations. These four
questions should be left blank for firms not subject to HACCP regulations.

Section IV. INSPECTIONAL OBSERVATIONS AND PERFORMANCE FOR PC LIMITED SCOPE AND MODIFIED
SCOPE AUDITS
• Question one applies to ALL audits performed including food, seafood and juice and should be answered
for every audit.
• Questions 2, 3, and 4 should be marked Not Applicable when a firm is not subject to the regulation.
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 contract inspectors who receive an overall audit score of "needs improvement" shall receive remedial training in
deficient areas or as agreed upon by the state and FDA Division prior to resuming contract inspection duties.

FORM FDA 3610 (03/2020)

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