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
- Self-Populating:
- Who wrote each section of the EIR?
- Any other in-plant inspectors or agencies? If so, what was your interaction?
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
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
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Where are some of the firm's raw materials suppliers located? (Name, City, State, or County)
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Where were the actual Raw Materials shipped from If different from above?
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Did you collect InterState documentation for violative product(s) containing ingredients shipped in interstate commerce?
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
- 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
- Does the firm meet the Juice HACCP training requirements?
- What is the firm's training program?
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
- 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
- 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
- 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
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
- 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
- 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
- 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.
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
- Does the firm have a recall procedure? If yes, explain.
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?
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
- 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
- What deficiencies were corrected since the previous inspection?
- Did the firm make any voluntary corrections during the inspection? If so, explain.
Exhibits Collected
- What exhibits did you collect? List by number with brief description.
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.
Publication date: Oct. 7, 2015
Revised: July 12, 2023
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