1. Enforcement Basics Mark Mansour, Jones Day Elaine Messa, NSF Health Sciences Marcela Rios Vessell, Integra LifeSciences Michael Viscido, IKARIA, Inc. Nancy Singer, Compliance-Alliance, LLC

2. Question 1 The FDA investigator refuses to provide a daily briefing in a medical device inspection. 2

3. Question 2 The FDA investigator states that if you refuse to provide all of your complaints back to 2003, he will consider this to be an inspection refusal and note this on the EIR. 3

4. Question 3 You discover that one of your employees has falsified information during complaint investigations in order to clear up the backlog of complaints. You correct the situation. Do you report this to the FDA, or bring it up during the next inspection? 4

5. Question 4 You see an employee who has received notice that he will be laid off in two weeks talking to an investigator. 5

6. Question 5 During the discussion with management at your facility in New Jersey, you receive a 483 with a number of significant observations. The national expert mentions that this year she had been at your facilities in Florida and Puerto Rico. What action do you take after the investigator leaves? 6

7. Question 6 The US marshal arrives at your facility with a warrant of arrest to seize all finished products. 7

8. Question 7 Your products are stopped in the LA port of entry. You call the head of the Import Division in LA and learn that your products are subject to an import alert. The grounds for the import alert was an OAI inspection by FDA of your facility in Spain. 8

9. Question 8 On your most recent inspection, two of the eleven items on the 483 were marked as repeat observations. How do you approach your response to those observations? 9

10. Question 9 A man says he is from the FDA and shows a badge, but says that he left the FDA 482 back at the office. 10

11. Question 10 You have had two inspections with numerous 483 items on them. During the recent inspection of your facility many of the items were repeat observations. You need to brief your management on the types of enforcement actions FDA can take against your firm. What do you tell them? 11

12. Question 11 The FDA investigator asks for a document. You say it will take four days to get it. The FDA investigator says he believes this is a circumstance that could fall within the criteria outlined in the new guidance for delaying a drug inspection. What do you do? 12

13. Number of 483 Observation 9/30/12 – 9/30/2013 http://www.fda.gov/ICECI/Inspections/ucm381526.htm#devices

14. Navigation Guides -www.fda.gov -Inspections, Compliance, Enforcement, and Criminal Investigations -Inspection Observations

16. Top 5 Food 483 Citations

17. Top 5 Drug 483 Citations

18. Top 5 Device 483 Citations