Juice Inspection Tool

• 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 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.

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?

• 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?

• 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?

• Does the firm meet the Juice HACCP training requirements?
• What is the firm's training program?

• 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?

• 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.

• 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?

• 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

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.

• 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.

• 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.

• 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 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?

• Does the firm have a recall procedure? If yes, explain.

• 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?

• 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.

• 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.