This document provides an overview and guidance for preparing for and responding to a FDA inspection. It discusses having necessary documentation and quality systems in place. When the FDA calls to schedule an inspection, it is important to pull together an inspection team and prepare by reviewing documentation, conducting mock audits, and training employees. During the inspection, the FDA will observe operations, interview staff, and review records. It is important to escort the inspector, answer questions truthfully, and only provide requested documentation. After the inspection, any findings or Form 483 observations must be addressed and corrections provided to the FDA within a specified timeframe.

1. FDA Just Called!
Now What?
Linda Chatwin, Esq. RAC
Advisory Services
UL LLC
and
Walt Murray
Quality & Compliance Consulting Services
MasterControl Inc.

2. AGENDA
• What to do to be in a constant state of readiness (5 min)
• When FDA calls to schedule the inspection (20 Min)
• Steps to take
• Preparations to make
• Training to give
• When FDA shows at the door (15 min)
• What if they haven’t scheduled the inspection?
• Who to call – what to have ready
• After the inspection – what is next (10 Min)
• Q&A (10 Min)

3. Preparing for the Inspection
• FDA policy and procedure in place
• Internal audit - State of the company internal audit history
• Previous external audits (Customer, Supplier, FDA)
• Major “horizon” items to tackle (e.g., objectives, planning
efforts, what’s coming up that will impact your quality
system?)
• State of your supplier controls, quality agreements
• Mock audit to prepare for FDA inspections
“The best way to survive an FDA audit is to be prepared!”

4. Purpose of Inspection
• Checking procedure against practice (“…say you what do”)
• Checking practice against procedure (“…do what you say”)
• Checking records against procedure (“…prove it”)
• Checking to see if the practice is effective, and if it meets QSR
requirements
• An OPEN BOOK “test” of the system

5. Purpose - Continued
• A sampling of a process or activity at a point in time
• An assessment of a system (and processes of the
system) to determine if it is conforming to applicable
requirements
• An assessment of system effectiveness

6. You Just Got the Call
• Reality Check! What’s your current state?
• All hands on deck
• Review your “How to Handle an Audit Plan”
• Who to pull together (Teams)
• Roles and responsibilities need to be defined
• Receptionist – Needs to know the people to
call
• Get the meeting room ready
• Go to the room that the inspection takes
place
• Train the teams and team members

7. Inspection Preparation
• Know the Quality System Requirements and the Quality
Policy
• Check for and remove unnecessary - uncontrolled posted
documents
• Beware of informal posted reminders
• Be sure charts and graphs are up-to-date and correct
• Keep work areas neat
• Perform Internal and 3rd party Mock audits
• Ensure that processes are documented, and that work is
properly recorded

8. Let’s Look Great
• Prepare an org chart to give to investigator when he/she arrives
• Have a short presentation ready to show off the company quality beliefs.
• Have a tour route and tour guide(s) planned
• Review your manufacturing facility … is it clean, free of cheat sheets, etc.?
• Train all who will be involved in the inspection. Don’t forget the
manufacturing department … make sure they’re able to articulate what
they do, how it relates to the product and what could go wrong.
• Do’s and Don’ts checklist
• Setup the War Room

9. Quality System Inspection
Technique (QSIT)
What will they do?
• Observing activities
• Interviewing employees
• Reviewing records
• Looking at the documented
procedures and requirements

10. Do’s During the Inspection
DO – Ensure inspector is escorted at all times.
DO – Be courteous, but not talkative
DO – Be truthful – I don’t know but I will get the answer for you is a good response
DO – Understand what FDA is entitled to and what they are not entitled to
• Quality records and documents, yes.
• Identify truly confidential info as such
• Management Reviews, Internal Audits and financial records, no.

11. Do’s (Cont)
DO – Answer ONLY what is asked. Get
clarification if needed
DO – Have “war room” prepare documents
requested and keep record and copy of what is
provided.

12. Dont’s During the Inspection
DON’T – Offer information
DON’T – Refer to uncontrolled documents
DON’T – Answer questions for others
DON’T – Air concerns about processes
DON’T – Offer gifts, lunches, gratuity
DON’T – Answer questions when you think you know the answer

13. Ding Dong
It’s not the Avon lady (FDA Arrives)
• Make sure the a auditor signs in
• Always have an escort for the investigator
• Have a war room & room for the auditor
• Gather the correct people (Code Blue)
• Opening Meeting presentation

14. Day of Arrival
• Present Credentials – Badge and Form – Notice of Inspection (Form 482)
• Reception have a contact list
• Have an usher to primary escort
• Opening meeting – set up and room arranged
• Separate room for inspection activities
• “War room” operational
• Tour of facility

15. Types of Inspections
• Pre-announced
• May receive up to 2 weeks advanced notice or more
• Generally routine inspections
• Directed
• Usually not announced
• For cause
• Follow-up
• Make sure you know which it is
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm244267.htm

16. Logistics
• Realize what the inspector is doing during the tour
• Ensure employees are versed in responses – and know
what can go wrong if they don’t do their work correctly
• Be prepared with logs of complaints and CAPA – leave
internal audit and management review actions out
• ASK FDA for an end of day summary
• Have a meeting with team right after to see if you can
correct findings
• Hold “How’d It Go” team debrief

17. Daily Recaps
• If the auditor does not provide daily
recaps, have them internally
• After the auditor leaves for day, plan for
next day
• If there are going to be findings, try to
make fixes before auditor leaves
http://www.mastercontrol.com/FDA/Link to Videos on this subject >

18. Points to Ponder
• Differences between notified body auditing
technique (looking at process) and FDA (looking
for product risk).
• FDA audit hierarchy…CAPA, complaints, etc.
• Investigator does not have the final say…it will
go to compliance review

19. ISO 13485 / Notified Body FDA Inspection
Ongoing business relationship established between
manufacturer and assessment team
Public health, paid for by public funds –
Enforcement mentality
Process Inspection – with an agenda, so manufacturer
knows which processes will be reviewed
Systems inspection – no set agenda.
Defined time limit – Assessors rely on manufacturer for
payment to sustain business
Undefined time for onsite inspection – public funds pay inspectors
regardless of number of inspections completed
Scheduled visit May be unannounced and a surprise inspection
No limitations on what can be audited Specific limitations on what records can be audited –
No Management Review or Internal Audits
Comparison QSR 820 to ISO 13485
Notable differences between ISO 13485 / Notified Body audit and FDA Inspection:

21. Closing Meeting
• Auditor will give a list of 483’s (findings)
• Will explain the findings – will sound as if an
entire process is lacking
• If corrections have been made, ask auditor to
note it in the finding
• Auditor will discuss response requirements
• Auditor will check out of facility
FDA
Auditor

22. What’s Next?
• Next steps…respond to 483
within 15 days
• Write to FDA after 30 days to
request your EIR
• Further actions

23. One More Comment
• Watch for open ended questions
• Don’t spill the beans
• Understand the uses of your information
• Investigations are risk based

24. Questions
& Answers

25. Thank you
Linda Chatwin, Esq, RAC
UL Medical Regulatory Advisory Services
T: 1-360-815-5556
E: linda.chatwin@ul.com
W: ulmedicaladvisory.com
Walt Murray
Master Control QCC Services
T: 801-680-3623
E: wmurray@mastercontrol.com
W: www.mastercontrol.com
For more information
on FDA regulations and to view videos
on this subject, visit the link below.
http://www.mastercontrol.com/FDA