How To Avoid and Respond to FDA 483's and Warning Letters

May 26th, 2016

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

FDA Inspection

Preparing Ahead of Time

EVERY2 YEARS

FDA Will Review Your Quality System

Use Internal Quality Audits to Your Advantage

ISO 13485 Certification Doesn’t Matter to FDA

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 Inspection

It’s Showtime

• 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

Expect FDA Inspection to last minimum of 5 – 7 days

• 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

FDA Inspection

Time to Respond

• 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 Inspection

Data & Statistics

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)

Top 9 Reasons for 483 Observations in

2015 by CFR Clause

Top 9 Reasons for Warning Letter

Citations in 2015 by CFR Clause

Overall Problem Areas for Medical

Device Companies

FDA Inspection

The BIG Three

40%of 483 Observations

51%of WL Citations

Design Controls + CAPA + Complaints

Design Controls

Corrective & Preventive Action

Complaint Handling

Jon Speer@creoquality / @greenlightguru

Jon.Speer@greenlight.guru

+1 (317) 960-4280

View Our Software at

http://greenlight.guru

Q&A