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
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?
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
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
• 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
• 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
• 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
• 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
• 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
• 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
• 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?
Bonus:
Download the complete guide and get your free 483 response template at
http://blog.greenlight.guru/fda-483-warning-letters
• 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
FDA Medical Device QS Surveillance
Inspections CY2008 – CY2015
(Source: 2015 Annual FDA Medical Device Quality System Data)
• 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
FDA Inspectional Observations CY2004-
CY2015 by QS Subsystem
(Source: 2015 Annual FDA Medical Device Quality System Data)
Jon Speer@creoquality / @greenlightguru
+1 (317) 960-4280
View Our Software at
http://greenlight.guru
Q&A