FDA Just Called!Now What?Linda Chatwin, Esq. RACAdvisory ServicesUL LLCandWalt MurrayQuality & Compliance Consulting ServicesMasterControl Inc.

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)

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!”

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

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

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

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

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

Quality System Inspection Technique (QSIT)

What will they do?

• Observing activities• Interviewing employees• Reviewing records• Looking at the documented

procedures and requirements

Do’s During the InspectionDO – Ensure inspector is escorted at all times. DO – Be courteous, but not talkativeDO – Be truthful – I don’t know but I will get the answer for you is a good responseDO – 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.

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.

Dont’s During the Inspection

DON’T – Offer informationDON’T – Refer to uncontrolled documentsDON’T – Answer questions for othersDON’T – Air concerns about processesDON’T – Offer gifts, lunches, gratuityDON’T – Answer questions when you think you know the answer

Ding DongIt’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

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

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 ishttp://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm244267.htm

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

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 >

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

ISO 13485 / Notified Body FDA InspectionOngoing business relationship established between

manufacturer and assessment teamPublic health, paid for by public funds –Enforcement mentality

Process Inspection – with an agenda, so manufacturerknows 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 inspectorsregardless 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 13485Notable differences between ISO 13485 / Notified Body audit and FDA

Inspection:

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

FDAAuditor

What’s Next?• Next steps…respond to

483 within 15 days• Write to FDA after 30 days

to request your EIR • Further actions

One More Comment

• Watch for open ended questions • Don’t spill the beans • Understand the uses of your

information• Investigations are risk based

Questions& Answers

Thank you

Linda Chatwin, Esq, RACUL Medical Regulatory Advisory Services

T: 1-360-815-5556E: linda.chatwin@ul.comW: ulmedicaladvisory.com

Walt Murray Master Control QCC Services

T: 801-680-3623E: wmurray@mastercontrol.comW: www.mastercontrol.com

For more informationon FDA regulations and to view videos

on this subject, visit the link below.

http://www.mastercontrol.com/FDA