FDA Audit - The Do and Don't List

Do’s and Don’ts
During An FDA Inspection
Copyrighted 2013 Compliance Insight, Inc.

When dealing with the FDA investigator,
we should demonstrate knowledge of and
confidence in our quality system.
Not arrogant nor defiant…
The DO’s During an Inspection

* Never give false data, always tell
the truth
* Is it OK to say “I don’t know”?
* The investigator may ask the same
question to different people at
different times
The DON’Ts During an Inspection
Copyrighted 2013 Compliance
Insight, Inc.

 There are some “tricks”
used to pull information
from you during the
audit
 Be aware of what you are
saying and doing
 The “dome of silence”
 The tendency of people
to try to fill a void with
more information
 Talk, offer more info
 The “Hmmm… factor”
 Ask a question, write it
down, shake your head or
get a concerned look
 People take this as a
“problem” and then offer
more info to fill the gap
Insight, Inc.

If the investigator asks you for
some information, do not:
* make them ask for it again
* wait to see if they forget about
the request
Insight, Inc.

* It is not productive to argue with the investigator
when responding to a question or observation
* Don’t challenge the investigator. There is no
need for that. It only motivates curiosity and
questions.

* Do not stand around making faces and looking
worried. This makes people feel nervous and may
alert the investigator that something may be
wrong.
* Act confident and proud, not defensive.
* If a fellow employee is being questioned, do not try
to help them by answering the questions yourself or
by giving contradictory information.

* Do not interrupt the investigator or other
employees when they are speaking
* Do not talk loud or speak with the others
when the investigator is trying to
concentrate, read or review documentation.
* It is not your job to fill an uncomfortable
silence with additional explanation.

Loos
e
lips
sink
ships
Don’t talk – even off
site!!! Copyrighted 2013 Compliance Insight, Inc.

Things To Remember
During An FDA Inspection

* If it isn’t documented, it
doesn’t exist
Things to Remember During an Audit
Insight, Inc.

* Investigator may
“read” your body
language
* Be aware of your
body language
Insight, Inc.

* During the inspection,
observe and learn to
“read” the Investigator’s
body language.
Insight, Inc.

* Verbal ~7%
* Paralinguistic ~38%
* Non-Verbal ~55%
Communication
Insight, Inc.

* Intimate zone 0-1½ ft.
* Personal zone1½-4 ft.
* Social zone 4-12 ft.
Interview Orientation
Insight, Inc.

* Establish the “normal” behavior patterns
So that you are aware of behavioral changes
Interview Techniques
Insight, Inc.

* Upright
* Open & Relaxed
* Lean forward on occasion
* Aligned with Investigator
* Casual Posture Change
Truthful Posture
Insight, Inc.

* Retreating
* Slouching
* Frozen
* Not aligned
* Barrier Posture
* Consistent posture changes
* Head & Body Slump
Deceptive Posture
Insight, Inc.

* Composed
* Concerned/Realistic
* Cooperative
* Direct/Spontaneous
* Open/Helpful
* Sincere
* Confident
* Persistent/Consistent
Truthful Behaviors
Insight, Inc.

* Overly Anxious
* Unconcerned/Unrealistic
* Uncooperative/Defensive
* Guarded/Evasive/Hesitant
* Rationalizing/Unhelpful
* Insincere
* Defeated
* Apologetic/Accepting
* Quiet
Deceptive Behaviors
Insight, Inc.

Breaking a Gaze
Right = edit or
fabricate
Left = access memory
I wonder if
he’ll
believe
this?
Yes, that is
how it was
done
About 85%
accurate but
use only as a
tool to
determine if
further
questions
need to beCopyrighted 2013 Compliance
Insight, Inc.

* Stick to the facts not opinions. Do not use
phrases such as:
I think …
I’m not sure but …
In my opinion, it should …
What you are saying is not true…
Honestly… Usually… Typically…
As I recall…

* Listen to questions carefully
* Answer only what is asked. Do not volunteer
information
* Clarify what you don’t understand before
answering the question
* When a question is too broad, ask for specifics
Insight, Inc.

* If you don’t know the answer, say so. It is all
right to say that you need to look into the
situation further before answering.
* Do not guess if you’re not sure of the answer.
Look it up in the procedure and or consult you
peers, or another SME.
* If you are not a SME for a question asked, do not
answer the question and explain to FDA this fact
and get the right person.

If you think that the investigator has misunderstood
something
* say so immediately
* explain why in a professional manner

Phrases to Refrain From!
* That’s the way we’ve always done it
* Off the record…
* I probably shouldn’t say this but…
* Who, me?
* … Uh, no
* It’s probably a mistake.

* If we would do it that way we would never get anything done
* We don’t have enough time or resources to follow that procedure
* I do it a different way because the procedure is not good
* If you think that’s bad you should see this...
* We fixed that problem by firing the person
* That’s not my fault, that was the previous supervisor …
* That’s not my problem, that’s Quality Assurance’s problem
* Write it on the FDA-483, it’s the only way we can correct it.
Phrases to Refrain From!

Documents and Records
The investigator is permitted to review :
 Documents and records pertaining to
the control, manufacturing or quality
assurance activities within the facility,
as required by applicable federal
regulations.
 These include (but are not limited to):
 Procedures
 Batch Records
 Regulatory Filings
 Quality Control Procedures
 Validation records
 Calibration/PM records
 Investigations
 Other records such as training
records, job descriptions,
procedures, promotional labeling
etc., as defined in relevant parts
of the FDA regulation unless
otherwise specified.
Documents that can not be reviewed
by FDA:
 Reports of audits performed by
internal auditors, customers,
external auditors or consultants
 Records and documents
pertaining to the financial
matters of the company (sales
data, pricing information, etc.)
 Research data/protocols (true
“research” data is exempt from
review, product development
data can be reviewed by FDA)
 Personnel records other than
training
 Management review meeting
minutes

What happens if an investigator finds something wrong?
Answer:
 Discuss concern/finding with investigator so you fully understand
what the investigator understands. There should be no
misconceptions. Ask questions.
 At the end of each day, we request an oral list of all observations.
This gives us an opportunity to address issues before the close of
the inspection and allows us to prepare responses to potential 483
observations.
 At the conclusion of the inspection, the investigator presents
significant findings at the closing meeting on a FDA 483, List of
Observations.
 If the findings are minor, the investigator may opt to do nothing
except verbally advise the Regulatory representative and
management of the concerns.
Frequently Asked Questions

What happens if an investigator find something wrong?
Answer (continued):
 Your firm will respond in writing to the Form 483 with a
corrective action plan.
 We have to act quickly but effectively.
 Corrective Action Plan should address specific
observations, systemic correction and time frame for
implementing corrective actions.
Frequently Asked Questions

Compliance Insight, Inc.
513-860-3512
For a Free Consultation
www.Compliance-Insight.com

FDA Audit - The Do and Don't List

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