Understand and Survive an

FDA Inspection

Karen S. Ginsbury, Bpharm, MSc, MRPharmS

IVT’s 4th Annual Validation Week

Copenhagen, Denmark

March 2013

Agenda

• Pre-inspection

• The inspection

• After the inspection

Pre-Inspection

• Six weeks to one month notice – and they will want to see production going on

• MUST reply to the notice of inspection – fast. Only propose delay IF there is a valid reason e.g. you know there is a planned shutdown and tell FDA that saying “we are happy to host the inspection at the proposed dates, but we wish to clarify that we have a planned maintenance shutdown from … to … and we will not be producing any of our USA market products at that time.

Preparations

• NOTIFY management and SMEs – especially

the SMEs who need to start revising for their

exam because we don’t want them saying

“give me the deviation so I can remember

what happened”

• Management assigns a person who is IN

CHARGE of the inspection OR that is already

known in the company / in a job description –

they will MANAGE the preparations

Preparations

• Prepare a detailed checklist:

– REVIEW actions (CAPAs) to previous inspection findings and similar issues to make sure they are now compliant

– All deviations from the past two years

– All change controls as above

– All CAPA items: complaints, OOS results, rejected batches, rejected in-process material, maintenance records, logbooks…internal audit findings (COMPANY CONFIDENTIAL)

– (Training records)

Preparations

• Company walk-through – gross signs of housekeeping issues and documentation – all those unsigned notices pasted up with operating ranges, instructions etc. Printouts lying around in the QC lab with no accompanying test or notebook, “my copy” of an SOP

• War room – for the inspection we have an inspection room – a meeting assigned ONLY for that purpose and entry is by invite only

Preparations

• Assign a scribe or two – someone who

writes up non-stop the course of the

inspection – every time the inspector is

writing – the scribe is writing

• Assign someone (it might be the scribe)

who writes down requests – any document

that is requested

Keep the inspector Happy

• Prepare an opening presentation – SHORT and to the point

• A few details about the company history

• Organogram

• Number of employees and QA/QC employees

• Layout of the production area

• Have a printed copy ready for the inspector along with business cards of the key personnel who are introduced at the opening meeting

• Between 10 minutes to 30 minutes or you can have a continuation for a first time inspection with more detail which you offer as an option

Keep the inspector Happy

• We assume you are guilty: cheats, thieves and liars - their starting point is NOT that you are OK

• Put yourself in their shoes

• DON’T interrupt them. If they are writing – you write as well or the scribe does and let them get on with it – DO NOT interrupt their train of thought

• Someone (SME) comes into the room to present – they sit down WITH PHONE OFF and WAIT until asked

Dos and Don’ts

• NEVER ever lie – always answer truthfully but don’t rush to tell what you perceive as the WHOLE truth

• Listen carefully to the question

• Answer ONLY the question you were asked

• Wait until the inspector has FINISHED asking the question

• If the inspector is silent don’t panic – just WAIT – DON’T talk

Dos and Don’ts

• An employee or anyone under stress does NOT have to answer in English – there can be anyone in the room who is authorised who can translate their answer

• Keep your really “enthusiastic” guys WELL away from the inspector or give them a vacation.

• THE INSPECTOR may be able to speak or understand your native language – THEY ALL understand body language

• “the huddle” – they ask a question and five of your guys, go pale and start whispering for a few minutes in frantic tones and then say “yes”

Dos and Don’ts

• Once you say “no” it’s hard to gain

credibility for “yes”

• IF you have any document that is seriously

close to what is being asked for present it

• Don’t be shy to ask them to repeat a

question

• Don’t be shy to ask them to clarify a

question

Dos and Don’ts

• An SME needs “context” for a question so

the person who hears the question needs

to try and capture that on the document

request form

• All documents brought to the inspector

should be reviewed for absence of sticky

notes, pencilled annotations etc.

Good and Bad Phrases

• Bad – is “that’s not good science”

• That’s not what FDA wants

• Interrupt the inspector mid sentence and

tell them “it’s really important…”

• Good: “we thought this was the right thing

to do and would like to try to explain but if

it is wrong we will put it right”

Asking for explanations

• Be cautious – the FDA is not your GMP

consultant – You are supposed to be

familiar with the regulations

Site tour

• Don’t have a million people tagging along

• Don’t show off – throughout the inspection

– you don’t want to look good – you want

to pass the inspection

• Don’t volunteer information

Site metrics

• If you normally have them up – and it is a

quality tool – leave it there

• Don’t get into a slanging match – if you

don’t agree with the inspector –

respectfully try to present your point of

view – once but then just say we

understand your concern and will address

• Don’t do quick fixes

Wrap up meeting

• They present the findings

• DON’T try to respond to each one – just

commit to putting things right voluntarily

• IF there is something really inaccurate say

so.

response

• GET a detailed targeted response in

within 15 working days or you will get a

warning letter.