- 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?
- Self Populating:
- Who wrote each section of the EIR?
- Any other in plant inspectors or agencies? if so, what was your interaction?
- 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 in which correspondence should be sent?
- Is the firm registered? If not, did you provide them registration information?
- What are the firm's hours of business? Days/Seasons?
- Has the flrm 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 of the state (or exported to the U.S. when conducting foreign Inspections)?
- Did you collect IS documentation for the most recent shipment of each violative finished product?
Raw Materials [301(k)] — document when raw materials are received In IS
- Where are some of the firm's raw materials suppliers located? (Name, City, State or Countty)
- Where were the actual Raw Materials shipped from If different from above?
- Did you collect IS documentation for violative product containing ingredients shipped in interstate commerce?
- 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 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 to?
- What was his/her position, 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 areas of 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 trainlng program?
- What products were being processed during the inspection?
- What products did you inspect finished packaged, stored - full description?
- For the products 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?
- Does the firm have a sanitation program for their equipment? if yes, provide a general explanadøn.
- Does the firm have a sanitation program for covering employee practices and process gear, etc? If yes, provide a general explanation.
- 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 rek&d hazards? (per the Gulde)
- 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 anatysis? If not, explain.
- Were you able to resolve any differences? If so, explain?
- Did you collect any documentation to submit to CFSAN regardlng 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 that are 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 fin's HACCP plan, are the controls In place? Explain.
- Which of the 8 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.
- 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.
- 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 or In the firm's complaint system that are related to food safety? If so, explain.
- If yes, did the arm re-evaluate their HACCP plan to ensure that it was adequate in light of the complaint?
- 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 FDA?
- FDA 483 observations load Into Turbo EIR automatically
- For team inspections, did you identify which team member that was 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?
- 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.
- 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.
- What exhibits did you collect? List by number with brief description.
- 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
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