The 10 Best — and 10 Worst —
Things to Do When FDA Staff Are on
Site to Conduct an Inspection
A Panel Discussion:
Elaine Messa
Vicky Stoakes
Joe Famiglietti
David Elder
FDA Expectations
• FDA conducts inspections to assess
compliance with applicable laws and
regulations
• FDA expects:
– Investigators to conduct inspections in a
reasonable manner
– Industry to welcome the investigator
professionally and do all they can to facilitate an
efficient inspection
FDA Expectations (cont.)
• FDA expects:
– For minimal delays to occur at the outset of
unannounced inspections; no delays when the
inspection was preannounced
– For investigators to conduct efficient inspections
with as little disruption to operations as possible
– For information to be provided as swiftly as
possible without delay; if you don’t know the
answer, explain you don’t and get the person who
does know as soon as you can
FDA Expectations (cont.)
• FDA expects:
– For copies of records to be provided in a timely
manner
– That inspected parties will be nervous (it’s ok, the
investigator is too!)
– To be provided with access to all locations and
records related to the manufacturing process;
which means every step of the way (no “secret”
rooms)
FDA Expectations (cont.)
• FDA expects:
– Courtesy and respect shown by all parties
– Investigators to openly communicate the scope of
the inspection and findings at least daily
– For contentious issues to arise and for there to be
open dialogue; communicate to avoid
misunderstanding
– For industry to have procedures for
inspections/audits
– For there to be a “war room”
Question #1 for Panel Discussion
Are there common mistakes firms
make within the initial hours of the
inspection?
Question #2 for Panel Discussion
Can you offer a gift, coffee or lunch to
the FDA Investigator? Is it different
for US vs. OUS inspections?
Question #3 for Panel Discussion
What should you do if you do not
know the answer to a question asked
by the FDA investigator?
Part B: What should you do if you
realize an earlier answer was
incorrect?
Question #4 for Panel Discussion
The FDA Investigator is asking
questions to line operators on the
manufacturing floor, what should we
do?
Question #5 for Panel Discussion
Is it acceptable for FDA Investigators
to ask for access to computer systems
or for database downloads onto CD or
flash drive?
Question #6 for Panel Discussion
At the opening meeting we informed the
FDA Investigator that we have a policy
that does not allow photography but she
saw a puddle under my WFI holding tank
and just took out her camera, how can I
stop her from snapping a picture?
Question #7 for Panel Discussion
What is the biggest mistake you have
seen companies make in the “Back
Room” process?
Question #8 for Panel Discussion
During the inspection, is it
appropriate for attorneys or
consultants to speak of the firm’s
behalf?
Question #9 for Panel Discussion
What should firms do if they believe
an FDA Investigator is acting
improperly (e.g. non-communicative,
will not hold a “daily debrief,”
inconsiderate/unprofessional)?
Question #10 for Panel Discussion
The inspection is nearing completion
and our closeout discussion is
beginning – we just want it to end
and we want the FDA Investigator out
of the site as quickly as possible,
right?
Question #11 for Panel Discussion
What should we do if we disagree
with an FDA-483 observation or
believe that the FDA Investigator is
wrong in his facts or conclusion?
Inspection Efficiency
Do…
• Have a procedure for hosting
inspections and follow your
procedure from beginning to end
• Prepare and maintain a site
overview slide deck that can be
accessed immediately and cover
key people, operations, products,
and physical layout of the site
• Make the back room run like a Swiss
watch
• Promptly respond to requests the
first time they are asked
Don’t…
• Think you can “wing it” without a
procedure or have a procedure but
then deviate from it without cause
or from inexperience
• Be surprised by, and unprepared
for, a health authority inspection
and then throw any available
resources towards its management
• Delay in responding to requests for
records or information.
• Make the agency request
information twice before getting it
Inspection Thoroughness and
Correctness
Do…
Don’t…
• Be honest, always, and without
exception
• Use subject matter experts
properly
• Assign scribes who can document
questions, requests for
documents, and persons
interviewed and who also
understand the bigger picture of
the inspection process and
company operations
• Be untruthful, deceptive, or
withhold relevant information
 Put SMEs before the agency who
have insufficient experience or
ineffective communication skills
 Use scribes simply as
stenographers (effective scribes
can be critical elements of the
process)
Inspection Professionalism
Do…
Don’t…
• Create a good first impression
• Identify the correct principal
liaison
• Identify the correct support
liaisons, who could take on the
role of principal in his/her
absence of when the inspection
takes parallel tracks
• Set up the inspection team in a
room of suitable size, lighting,
and temperature control
• Have an uninformed receptionist
who treats the Investigator as a
solicitor
• Select principal liaisons, who lack
the knowledge, savvy, or
interpersonal skills to be effective
• Forget to select and train more
than one principal liaison
• Seek to make the physical
environment or the operating
atmosphere unpleasant or
uncomfortable
Inspection Communication
Do…
Don’t…
• Assure prompt and effective
internal communication
throughout the process
• Assign scribes who can effectively
translate requests and discussion
points for collective awareness
(not merely record every word
spoken)
• ask questions of the investigators
and seek clarification of
observations or concerns
• Create any gaps in internal
communication
• Fail to observe any potential
areas of misunderstanding that
become apparent through the
questions, document requests,
and discussions
• Leaving misunderstandings
unresolved when the inspection
concludes
Overall Advice
• Treat the inspection process as an important
business activity and manage it accordingly
• For easily correctable items, take action while the
inspection is ongoing and demonstrate corrective
actions when completed
• Practice – conduct mock inspections of the overall
process, including: reception, introductions, site
overview, roles of top official, liaison, SME, and
scribe, back room functionality, and communication
system.