Mastering the Unannounced Regulatory Inspection

An unannounced inspection from the FDA - or other regulatory agency - could result in uncertainty and anxiety within your team. If someone does not clearly understand what the inspector is looking for, or can’t produce what is being asked of them, these mishaps might place the inspection at risk.

During this presentation you’ll learn what critical areas to prepare for should an unexpected regulatory inspection occur, along with training tips to help empower your team to navigate inspections with confidence.

Discussion items include:
• Understanding the scope of the inspection
• Critical documents that should be prepared
• Management and training processes to ensure an “always-ready” culture
• Planning tips to know who is responsible for what and when

Presented by Mary Hoffman, Sr. Director of Food Safety at The Acheson Group

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1. Mary Hoffman Sr. Director, Food Safety Mastering the Unannounced Regulatory Inspection

2. A global food safety and public health consulting group made up of seasoned industry experts Award-winning digital plant management platform to visualize plant-wide performance and better control quality, yield & production optimization. Brought to you by:

3. Meet Your FSMA Friday Speaker Mary Hoffman Sr. Director, Food Safety Mary has held technical and managerial positions at a variety of food production companies, directing corporate and facility-level quality, R&D, and laboratory teams. Specializing in manufacturing food safety and quality program development and improvement, Mary has held responsibility for recall and crisis management and overseeing compliance with regulatory, Global Food Safety Initiative (GFSI), and customer requirements. Mary has led proactive food safety initiatives including supply chain risk mitigation, allergen control, environmental controls and monitoring, microbiological testing, and behavior-based Good Manufacturing Practice (GMP) coaching programs.

4. FSMA: Regulatory Updates FDA shares updates on their efforts to better understand Per- and Polyfluoroalkyl Substances (PFAS) in the general food supply. Comment Period Reopened for the Draft Guidance on Sampling Recommendations for Seafood Subject to DWPE. FDA Issues Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements

5. Mastering the Unannounced Regulatory Inspection Preparing your team Managing the visit Document review Facility walkthrough Responding to observations Key takeaways Discussion

6. Managing Arrival Request to see the investigator’s credentials Conduct your normal visitor protocols (review of GMP and safety requirements, etc.). They may not sign them Notify relevant personnel – provide a list Escort the investigator to a conference room that will be used throughout the duration of the inspection Prepare front-line personnel (security guard, receptionist)

7. Opening Meeting Management commitment Determine purpose of visit Routine For Cause Customer complaint Foodborne illness report Test result Form 482 (outlines the purpose of the site visit) Cross functional site leadership representation

8. “Dear Investigator” Welcome letter/statement to be presented at opening meeting General overview of facility, processes and products Company policies GMPs Health/safety expectations while in production areas Required escort policy Documents sharing and confidentiality Photographs

9. Navigating the Document Review

10. Navigating the Document Review Specific to regulations Program requirements Implementation records Training records Know what is required Product recipes Financial or pricing information HR/personnel data Research data Quality programs Know what may be out of scope

11. General Info About Records Original, true copies, or electronic Accurate, indelible, legible Real-time recording of values Enough detail to provide a history of work performed Know and follow record retention requirements PCHF & IA Rules: ≥ 2 years after they were prepared

12. Preventative Controls for Human Food Hazard analysis Food Safety Plan Monitoring Records Verification Records Training records Recall plan Preventive controls Process (validation) Allergen Sanitation Supply Chain

13. Intentional Adulteration (IA) Rule Vulnerability assessment Mitigation strategies Monitoring Records Training records Food Defense Plan

14. Robust hazard analysis and decisions-based on scientific evidence and risk-based criteria are key

15. vs. vs. Monitoring Verification Validation

16. Corrective and Preventive Action (CAPA) Records Actions taken to identify and correct an issue Actions to reduce likelihood that the same issue will happen again An evaluation and disposition of all affected food Evidence that potentially unsafe food did not enter commerce

17. Customer/Consumer Complaints Food Safety vs. Quality Focus on Follow-Up Complaints as Verification in Food Safety Plan Complaints

18. Your Goal: To maintain a positive relationship with regulators and clearly exhibit that you are in compliance and appropriately controlling hazards

19. Managing the Facility Inspection

20. Walk-Through Basics Escort the inspector(s) Ask what specifically they would like to see Follow your facility’s standard practices GMPs/PPE

21. What if something goes wrong? Process Failures GMP Gaps Infrastructure Issues

22. TAG Comments Follow your standard protocols for responding to an incident which may include: Stopping the line Placing product on hold Establishing a clean break Identifying the root cause that led to the issue Whenever possible, correct issues right away and show evidence to the inspector while they are still onsite

23. Product Sampling Environmental Monitoring

24. TAG Recommendations Ask what organism(s) they are testing for Place product on hold pending results Conduct a clean break if appropriate Take notes and photographs If they take samples: Taking duplicate samples: Discuss company protocols in advance What would you do with the results?

25. Be Prepared with a Robust EMP! Know your facility – Don’t wait for regulators to find it for you Seek and Destroy Documented investigation and CAPA for positives Clean breaks to limit scope of implicated product

26. What if They Want to Take Photos?

27. Photos Option #1: Allow the Inspector to Take Photos If Company has no concerns about the request, allow the inspector to photographs Escort the inspector while they take the photos. Request to frame the photos to protect proprietary information Consider taking duplicate photos to facilitate later discussions with the agency and/or response to its actions

28. Photos Option #2: Enforcing a No-Photo/Video Policy Ensure that the policy is clearly communicated to the inspector right at the beginning of the meeting, including the reasons for not allowing picture taking (e.g., protection of trade secrets/business confidential information which upon disclosure may place the company at a competitive disadvantage) Carefully explain to FDA investigators that the intent is not to refuse or impede inspection Ensure that the policy has been applied equally with regulators, customers, etc., and posted prominently in relevant areas Engage your legal counsel/resource

29. TAG Comments Regulators may point to US court decisions to assert their right to take photos They may not ask for permission to take photos For discussion with your team: Is this worth the fight? If yes, thoroughly prepare your team to respond

30. Closing It Out Conduct a closing meeting to obtain the overall feedback from the FDA inspector Request that company receive a copy of the detailed Establishment Inspection Report (EIR) An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Respond in a timely manner. Any all comments, observations should have documented follow up

31. 5 Recommended Actions Regulatory Inspection Procedure Organize documents/records Review most recent inspection report and verify follow-up Review company policies (samples, photos) Conduct a Mock Regulatory Inspection

32. Mary Hoffman Sr. Director, Food Safety Mastering the Unannounced Regulatory Inspection