Hosting an FDA Inspection: A Field Investigator ’ s Perspective

1. Hosting an FDA Inspection: A Field Investigator’s Perspective Presented by Mihaly S. Ligmond Consumer Safety Officer US Food and Drug Administration, Division of Domestic Field Investigations PRCSQA/ORCANW Meeting November 2010

2. Objective To provide some information that a company may want to consider as to how to be prepared for, how to host, and how to respond to an FDA inspection Focus: cGMP/PAI Drug Inspections

3. Have basic documents up to date and ready Organizational Charts Floor Plans Production flow diagrams Company information Some Ways to be Prepared

4. Some Ways to be Prepared Have a plan but be flexible • Practice • SOP (notifications, interactions, etc.) • Understand your products

5. Some Ways to be Prepared Operate every day as if you were expecting an inspection Maintain training Keep the facility and equipment in good repair Address problems completely and in a timely manner

6. Hosting the Inspection Personnel • Have the right people available during walkthroughs, interviews, and presentation of documents • SMEs • Provide accurate information

7. Hosting the Inspection Facility • Suitable area • Document review mechanics

8. Hosting the Inspection Atmosphere • Demeanor • Try not to take comments personally • Respect the Investigator’s privacy • Address misunderstandings promptly, courteously, and with the facts • Don’t waste time

9. Hosting the Inspection Providing information • Answer questions truthfully and completely • Provide information that is requested promptly and completely • Clarify documentation requests if necessary • Provide accurate information • Try to bring everything at one time for a specific issue • A word about “slide shows”

10. Hosting the Inspection Interviews • Lower level employees • SMEs • Management • Have the most knowledgeable people available (during walkthroughs, presentations, etc.)

11. Hosting the Inspection Communication • With the Investigator (daily wrap-up meetings, clarifications, etc.) • Within the company • Address misunderstandings (show the data) • Discussion of potential Observations

12. Hosting the Inspection • A word about corrections made during the inspection to address the Investigator’s comments…

13. Hosting the Inspection The closeout meeting • Senior Management should be present • Ask questions if unclear • Discussions • Discussion items • Be clear on any disagreements

14. Responding Written responses…

15. Responding If no Form FDA 483 is issued… • Consider if a written response is warranted

16. Responding If a Form FDA 483 is issued… • Written response must be received within 15 business days if the company wants the response to be considered by the Agency in determining whether to issue a Warning Letter • Response should demonstrate that the observations have been fully addressed and/or corrected

17. Responding If a Form FDA 483 is issued… • Include reasonable timelines • Make a global response as needed • Include details and attachments as appropriate • Be comprehensive • Address any disagreements with the observations • Copy the Investigator

18. Summary Credibility is enhanced when a firm… • Is inspection ready • Hosts an inspection efficiently • Responds to issues effectively

19. Thank you Questions?