In this presentation from Validation Week Europe, Karen Ginsbury discusses the rigors, preparations, strategies, and the do's and the don't of the FDA Inspection process.

1. Understand and Survive an
FDA Inspection
Karen S. Ginsbury, Bpharm, MSc, MRPharmS
IVT’s 4th Annual Validation Week
Copenhagen, Denmark
March 2013

2. Agenda
• Pre-inspection
• The inspection
• After the inspection

3. 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.

4. 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

5. 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)

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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”

12. 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

13. 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.

14. 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”

15. Asking for explanations
• Be cautious – the FDA is not your GMP
consultant – You are supposed to be
familiar with the regulations

16. 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

17. Site metrics
• If you normally have them up – and it is a
quality tool – leave it there

18. • 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

19. 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.

20. response
• GET a detailed targeted response in
within 15 working days or you will get a
warning letter.