NC State Extension Publications


Skip to Summary
  • What Is the reason for the inspection?
  • What was the scope of your inspection? (HACCP, GMP, Consumer Complaint#, Compliance Follow-Up)
  • What products are handled by the firm? - general category
  • What was the classification and date of the previous (State and/or FDA) inspection, and were there any previous regulatory actions taken?
  • What product(s) did you cover during the inspection?
  • What were your findings?
  • What voluntary corrections were made?
  • What were the results of past inspections?
    • Were there samples taken during past Inspections that would help to support current regulatory action?
    • Were corrections made by the firm?
    • What samples were collected during the current inspection and why?

Administrative Data

Skip to Administrative Data
  • Self-Populating:
  • Who wrote each section of the EIR?
  • Any other in-plant inspectors or agencies? If so, what was your interaction?


Skip to History
  • What Is the legal status of the firm?
  • Is there a parent company (or corporation), and if so, what is the address of that and any other subsidiaries?
  • What are the names, titles, and addresses of top management officials to which correspondence should be sent?
  • Is the firm registered? If not, did you provide them with registration information?
  • What are the firm's hours of business? Days/Seasons?
  • Has the firm had any actual (not just recommended) previous regulatory actions and prior warnings? If so, list them.
  • What significant and relevant inspectional history pertains to the current Inspection?
  • Has the firm recalled any product since the previous inspection? If so, explain.

Interstate (IS) Commerce

Skip to Interstate (IS) Commerce

Finished Products [301(a)]

  • Who are the firm's regular customers, and where are they located? (Name, City, and State)
  • What Is the percentage of products shipped outside the state (or exported to the U.S. when conducting foreign Inspections)?
  • Did you collect InterState documentation for the most recent shipment of each violative finished product?

Raw Materials [301(k)] — document when raw materials are received In InterState

  • Where are some of the firm's raw materials suppliers located? (Name, City, State, or County)

  • Where were the actual Raw Materials shipped from If different from above?

  • Did you collect InterState documentation for violative product(s) containing ingredients shipped in interstate commerce?


Skip to Jurisdiction
  • Can the firm provide a list of finished products? If not, list finished products, including brands, trade names, and private labels.
  • Did you collect all "appropriate" labeling for products believed to be violative? Explain.
    • NOTE: See IOM for a discussion of "appropriate" labeling.
  • Does the firm have any labeling agreements? If so, did you collect a copy?
  • Does the firm have any statutory guarantees given or received? If so, did you collect a copy?

Persons Interviewed and Individual Responsibility

Skip to Persons Interviewed and Individual Responsibility
  • Who did you issue the FDA 482 and present credentials?
  • What was his/her position and title?
  • If not presented to top management, why?
  • Who are the key officers or managers at the firm and/or other locations? Owners, partners, or corporate officers of the firm, their titles, mailing addresses? (Note, you can get some of the information under the Administrative Section)
  • What are their specific responsibilities?
  • What did you see or hear that confirmed their responsibility?
  • Who accompanied you during the inspection?
  • Who participated in the final discussion with management?
  • Who promised corrections?

Firm's Training Program

Skip to Firm's Training Program
  • Does the firm meet the Juice HACCP training requirements?
  • What is the firm's training program?

Manufacturing Operations

Skip to Manufacturing Operations
  • What product(s) were being processed during the inspection?
  • What product(s) did you inspect in finished packaging and stored - full description?
  • For the product(s) you inspected – what is the product flow from receipt of raw materials through finished product storage?
    • Identify each process step, in order, and write a complete description of each step in the EIR.
    • Prepare a simple flow diagram to be used as an attachment to the EIR.
  • What was the firm's manufacturing coding system on the day of the inspection?
  • What is the interpretation of the manufacturing coding system?

Sanitation Procedures

Skip to Sanitation Procedures
  • Does the firm have a sanitation program for their equipment? If yes, provide a general explanation.
  • Does the firm have a sanitation program covering employee practices, processing equipment, etc? If yes, provide a general explanation.

Hazard Analysis

Skip to Hazard Analysis
  • What product/process did you inspect? (Include FP description, packaging, method of storage, and intended use)
  • What are the potential species-related hazards? (per the Guide)
  • What are the potential process related hazards? (per the Guide)
  • Based on your observations, which of these hazards are either "reasonably likely to occur" or not, and why?
  • Are the CCP's that you identlfled the same as those identified by the firm in their hazard analysis? If not, explain.
  • Were you able to resolve any differences? If so, explain?
  • Did you collect any documentation to submit to CFSAN regarding the differences?

Hazard Analysis / HACCP Plan

Skip to Hazard Analysis / HACCP Plan
  • Did you review the firm's hazard analysis for the product you inspected? If not, why?
  • Did you find deficiencies in the firm's hazard analysis? If so, what?
    • Relate each deficiency to the FDA-483 item under objectionable conditions.
  • Did you review the HACCP plan for the product you inspected? If not, why?
  • Did you find deficiencies in the firm's current HACCP plan? If so, what?
    • Relate each deficiency to the FDA 483 item under objectionable conditions

HACCP Plan Implementation

Skip to HACCP Plan Implementation

At each CCP:

  • Did you confirm that the firm is implementing the monitoring, verification, and corrective action procedures outlined in their HACCP Plan? Explain
    • Relate each deficiency to the FDA 483 Item under objectionable conditions.
  • If the firm does not have a HACCP plan and you identified a CCP that was not in the firm's HACCP plan, are the controls in place? Explain.

Sanitation Monitoring/Implementation

Skip to Sanitation Monitoring/Implementation
  • Which of the key areas of sanitation need to be monitored?
  • Does the facility monitor the areas that apply? If not, why?
  • Did you accompany the person doing the monitoring to see if the firm was implementing their sanitation monitoring? If not, why?
  • Did you find deficiencies in the firm's monitoring program? If yes, explain.
    • Relate each deficiency to the FDA-483 item under Objectionable conditions.

Record Review

Skip to Record Review
  • Did you review monitoring (including sanitation), verification, and corrective action records?
  • Over what time period?
  • What dates of records did you review?
  • Did you note record deficiencies during your review? If so, explain.
    • Relate each deficiency to the FDA-483 item under objectionable conditions.

Importer Verification Procedures

Skip to Importer Verification Procedures
  • Does the firm have written verification procedures for each foreign manufacturer/imported product combination you covered?
  • Does the firm have a product specification that identifies the product and process-related hazards?
  • Does the firm have an affirmative step for the foreign manufacturer/imported product combination you covered?
  • Is the firm deficient in any of the above areas? if so, explain.


Skip to Complaints
  • Did you conduct this inspection in follow-up to a complaint? If so, explain.
  • What was the firm's response to the complaint?
  • If this inspection is not in follow-up to a complaint, did the firm have any complaints in FACTS related to food safety or the firm's complaint system? If so, explain.
  • If yes, did the firm re-evaluate its HACCP plan to ensure it was adequate in light of the complaint?

Recall Procedures

Skip to Recall Procedures
  • Does the firm have a recall procedure? If yes, explain.

Objectionable Conditions and Management's Response

Skip to Objectionable Conditions and Management's Response
  • Who did you issue the FDA-483 to? (Name, title)
  • Who else was present during the close out discussion? (Name, title)
  • Did you provide the firm with a verbal warning about regulatory sanctions that are available to the FDA?
  • FDA-483 observations load into Turbo EIR automatically
    • For team inspections, did you identify which team member responsible for each observation?
  • Supporting evidence and relevance
    • Can you identify specific exhibits, samples, or labeling text that supports the documented violations? If yes, list.
    • Does the observation have an impact on the process and/or product that you inspected or any other products that the firm processes? If yes, explain.
    • Is the problem ongoing? If yes, explain.
  • Discussion with management
    • Who provided a response for each FDA-483 item?
    • What response was given for each FDA-483 item? (Corrective action, time frames, disagreements, etc)
  • General discussion
    • What other items were discussed with the firm that was not listed on the FDA-483?
    • What was management's response to these items?


Skip to Refusals
  • What refusals were encountered during your Inspection (entry, photography, monitoring records, etc)? If any, explain.
    • NOTE: if any refusals are encountered follow the procedures outlined in the IOM.

Samples Collected

Skip to Samples Collected
  • What samples did you collect during the Inspection? Why?
    • If sample results are known prior to writing the EIR, report the results.

Summary of Voluntary Corrections

Skip to Summary of Voluntary Corrections
  • What deficiencies were corrected since the previous inspection?
  • Did the firm make any voluntary corrections during the inspection? If so, explain.

Exhibits Collected

Skip to Exhibits Collected
  • What exhibits did you collect? List by number with brief description.


Skip to Attachments
  • Did you collect any materials that are not evidentiary (assignments, FDA forms such as FDA-482, FDA-483, flow diagram, etc.)? If so, list starting with FDA forms in form number order.

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Publication date: Oct. 7, 2015
Revised: July 12, 2023

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