How long has it been since your last FDA inspection? You know FDA is technically mandated to inspect any company with class II or class III products every two years (and inspections have been on the rise particularly for foreign / outside the US firms). If FDA called tomorrow to announce their plans to visit your facility next week would you be prepared? Even the most prepared companies still often find themselves receiving 483 observations. Then you must act swiftly and effectively to avoid that observation escalating to a warning letter. But what exactly do you do? How do you respond to FDA 483 observations and/or warning letters? greenlight.guru founder and VP QA/RA, Jon Speer, has been through his fair share of FDA inspections over the course of his 17+ year career in the medical device industry and has helped many of companies respond to 483 observations and warning letters along the way. In this free, 60 minutes webinar, Jon will be sharing his most effective tips on how to avoid 483’s and warning letters in the first place along with a step-by-step guide to responding the them if you do happen to receive either. (You can view the full webinar here: http://www.greenlight.guru/webinar/fda-483-warning-letter-response) Specifically you'll learn: What you should be doing to always be prepared for an FDA inspection How to help prep your team before an FDA inspection The top 7 reasons FDA issued medical device companies 483 observations and warning letters in FY2015 Tips you can implement today to mitigate your risk of getting 483’s and warning letters What you need to do before responding to a 483 to minimize the damage (and avoid the common pitfalls) Best practices for responding to FDA 483 and warning letter (including a free response template) The differences in responding to a 483 observation vs. a warning letter What to expect from FDA after submitting your response

1. How To Avoid and Respond to
FDA 483's and Warning Letters
May 26th, 2016

2. About the Presenter
Jon Speer is the Founder & VP QA/RA of
greenlight.guru.
• 17+ years in medical device industry
• Product development engineer, quality
manager, regulatory specialist
• 40+ products to market
• Expert at QMS implementations
• Dozens of ISO audits & FDA inspections
greenlight.guru produces beautifully simple
quality, design control and risk management
software exclusively for medical device
manufacturers.
View Our Software at
http://greenlight.guru

3. How long has it been since your last FDA
inspection?
If FDA called tomorrow to announce their plans
to visit your facility next week would you be
prepared?
What if FDA didn’t call and just showed up?
How do you respond to FDA 483 observations
and/or warning letters?

4. We’ll cover:
• What you should be doing to always be prepared for an FDA inspection
• How to help prep your team before an FDA inspection
• The top 7 reasons FDA issued medical device companies 483
observations and warning letters in FY2015
• Tips you can implement today to mitigate your risk of getting 483’s and
warning letters
• What you need to do before responding to a 483 to minimize the
damage (and avoid the common pitfalls)
• Best practices for responding to FDA 483 and warning letter (including a
free response template)
• The differences in responding to a 483 observation vs. a warning letter
• What to expect from FDA after submitting your response
Agenda

5. FDA Inspection
Preparing Ahead of Time

6. EVERY
2 YEARS

7. FDA Will Review Your Quality
System

8. Use Internal Quality Audits to
Your Advantage

9. ISO 13485 Certification Doesn’t
Matter to FDA

10. Prepare Your Team In advance
• Review “Guide to Inspections of
Quality Systems” (QSIT)
• Seek and conduct training
• Mock FDA inspections
• Define roles & responsibilities
• Always be ready
• Establishment Registration up-to-date
• All products properly registered

11. FDA Inspection
It’s Showtime

12. • FDA contacts you prior to inspection to schedule (or
could just show up)
• Start of inspection – FDA inspector presents
credentials and Form 482 Notice of Inspection
• FDA inspector explains purpose for inspection
(don’t expect an agenda)
• Likely to include a brief walkthrough
Start of the Inspection

13. • Do be ready to provide a (brief)
company overview
• Do have examples of products handy
• Do have someone with FDA inspector at
all times
• Do answer questions asked honestly
• Avoid small talk
FDA Inspection

14. • FDA inspector will dive right in
• Likely to begin with MDRs and complaints
• QSIT as a guide
• Strong focus on CAPAS
• Likely to be told of issues as identified
The Rest of the Inspection

16. Expect FDA Inspection to last
minimum of 5 – 7 days

17. • Do not feel obligated to try and resolve
issues while inspection is ongoing
• Ask for clarification and additional
explanation
• State your case supported with objective
evidence
FDA Inspection

18. • FDA inspector conduct a closing meeting
• Review any identified issues & provide draft of FDA
Form 483 Inspectional Observations
• Determination if you agree to correct
Wrapping Up the Inspection

19. FDA Inspection
Time to Respond

20. • Draft response to 483 Inspectional Observations
(within 15 business days)
• Cover Letter
• For each observation:
• Determine any immediate corrections
• Assess risks
• Identify root cause
• Initiate internal corrective action plans
• Estimate completion
• Provide frequent updates to FDA until completion
After the Inspection

21. • FDA works on an escalation process
• Response to 483 observations important
• Repeat infractions a factor
• Severity of infractions a factor
• If issued, you MUST respond and take action
• Warning Letter decision is up to FDA Office of
Compliance
Will You Get a Warning Letter?

22. Bonus:
Download the complete guide
and get your free 483
response template at
http://blog.greenlight.guru/fd
a-483-warning-letters

23. • Do restate each observation word for
word
• Do state root cause, risk, corrections,
corrective action plan, and estimated
completion date for each observation
• Do provide frequent updates to FDA
• Do hit your timelines communicated
FDA Inspection Response

24. FDA Inspection
Data & Statistics

25. FDA Medical Device QS Surveillance
Inspections CY2008 – CY2015
(Source: 2015 Annual FDA Medical Device Quality System Data)

26. • FDA conducted 2,104 medical device company
inspections
• FDA issued 483 Inspectional Observations to 924
companies
• Total of 3,525 483 Observations issued against FDA
21 CFR part 820
• FDA issued Warning Letters to 121 companies
• ~50% were foreign (OUS) establishments
• Total of 690 Warning Letter citations issued against
FDA 21 CFR part 820
FDA Inspections – 2015 Statistics

27. FDA Inspectional Observations CY2004-
CY2015 by QS Subsystem
(Source: 2015 Annual FDA Medical Device Quality System Data)

28. Top 9 Reasons for 483 Observations in
2015 by CFR Clause

29. Top 9 Reasons for Warning Letter
Citations in 2015 by CFR Clause

30. Overall Problem Areas for Medical
Device Companies

31. FDA Inspection
The BIG Three

32. 40%
of 483 Observations
51%
of WL Citations
Design Controls + CAPA + Complaints

33. Design Controls

34. Corrective & Preventive Action

35. Complaint Handling

36. Jon Speer
@creoquality / @greenlightguru
Jon.Speer@greenlight.guru
+1 (317) 960-4280
View Our Software at
http://greenlight.guru
Q&A