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FDA Inspection: Do & Don'ts
DARSHAN KULKARNI
PHARM.D, MS, ESQ
VP OF REGULATORY STRATEGY & POLICY,
SYNCHROGENIX

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2© Copyright 2017 Certara, L.P. All rights reserved.
Disclaimers
Not Legal Advice
Not intended to create an attorney client
relationship

Who here believes that we should:
Provide FDA with
ready access to the
site
Provide FDA
inspectors with
financial data e.g
Access to the CTA
Allow FDA to take any
and all original copies
of documents back to
HQ as long as they
promise to bring back
Take photographs
Require FDA to sign a
CDA before starting
Review products not
being investigated?

TYPES OF
ENFORCEMENT
ACTIVITIES

TYPES OF ENFORCEMENT
Civil & criminal Liability
Permanent Debarment of Firms or persons
Temporary Debarment of Firms or persons
Disqualification/ Restriction of Individuals
Corporate Integrity Agreements
Delayed or no further approval of sponsor applications
Injunction
Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE)
Warning Letter: Issued by district director/HQ official
483: Issued by Investigator at site

PLANNING FOR AN
ENFORCEMENT
ACTION
PRE- INSPECTION
DURING INSPECTION
POST RESPONSE

FDA is at the Door
Do I want to take
an aggressive
posture?
They can enter
What am I going to tell my investors?
What people will I allow them to interview?
What information am I going to allow them to
have?External
Factors
Internal
Factors
Respond
What am I going to tell my employees?
YesNoThey cannot enter
PLANNING FOR AN ENFORCEMENT ACTION

WHY ALLOW THE INSPECTION?FDA is doing its job. Its mandate is to
be:
"responsible for protecting the public health by assuring
the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices,
our nation’s food supply, cosmetics, and products that
emit radiation, and by regulating the
manufacture, marketing, and distribution of
tobacco products."

WHY ALLOW THE INSPECTION? CON
If the FDA is satisfied regarding
compliance, the company will be
subject to inspections of:
unlikely to be escalated to other enforcement
mechanisms (e.g. Warning letters etc.)
ordinary frequency
ordinary intensity

WHY ALLOW THE INSPECTION?
Delaying the
inevitable: They will
come back.
When they come
back, it will not be
"pretty"
You may
inadvertently
escalate a routine
inspection into
more.
Whatever you want
to hide, they may
already know it or
will often find out.
You want to be a
good corporate
citizen.
You want to lower
potential fines.

WHY ALLOW THE INSPECTION? CON
If you are not compliant you setup an
adversarial relationship which may
mean:
More
stringent
audits
Enhanced
compliance
measures
Enhanced
response
from the
FDA

WHY NOT ALLOW THE INSPECTION?
What they see, hear, touch,
and/or record constitutes
evidence.
Evidence:
You may inadvertently waive
privileges?
Privilege
You are exposing yourself to
potential liability and lawsuits.
Lawsuits

4 SEPARATE TEAMS
POC Inspection Team
Agency
Response
Team
Media
Response
Team

PRE- INSPECTION
PLANNING

DECISIONS TO MAKE BEFORE THE INSPECT
What information are you going to provide
access to?
Privileged
information
• Will you waive privilege?
• Can you partially waive privilege in your
state?
Access to
confidential
information
• Trade secrets?
Financial
Information
Internal
audit records

PRE-INSPECTION PLANNING
Creation of SOPs
Training
Audits
Choose the response team
Establish clear lines of communication

DECISIONS AND DISCUSSIONS
• Should non essential personnel go home?
Identify all non essential personnel.
• Will you cease operations for the day?
Will operations continue as normal?
Who should be present at the inspection table?
Roles of people in the team.
• Should the Sponsor/CRO rep be present (?)
For site/ CROs:

TONE SETTING DECISIONS
Will you let auditors in on presentation of the
482?
Will you record the meeting?
Will your lawyer be present?
Will you send people home?

IDENTIFICATION
Formulate email/
communication to
go to entire team.
Identify Point of
Contact
•Official Leader
•Official spokesman for team.
•Official Attorney
•Official Scribe (consider having 2)
•Individuals present in war room
•Individuals present in audit room
Identify
Inspections Team

COMPANY COMMUNICATION/ EMAIL
Keep it short and succinct.
Agency is here
Scope (if known)
Cooperate, but does not require volunteering information.
Reminder to insist that company lawyer must be present for
all interviews (escalates)
Other essential information.

POINTS OF CONTACT (POC)
First person to
know that the
agency is here.
Responsible for:
• Assembling
Inspection Team.
• Informing
Sponsor (if
required)
• Informing the
site that agency is
present.
• Dismissing non
essential
personnel
• Assembling war
room
There should be
multiple POCs (3-4
at least)

RESPONSE TEAM
All individuals who must be available to coordinate
response
May include:
• Leader
• Spokesperson
• Lawyer(s)
• Principal Investigator(s)
• Office Manager
• Scribe(s)
• Regulatory person(s)
• Sponsor representative (?)
• CRO representative (?)

Leader
Consults with all stake holders
Makes final decision and decides
official company position
Communicates through the
spokes person.
Determines direction/ tone/
scope of response.

Lawyer
Be present at
discussions
with
individuals.
Advises the
Leader
Determines: Does the FDA have the right to ask for the information?
Does it impact other on-going litigation?
Does it impact other prospective litigation?
Are you waiving privilege(s)?
Should be
someone
You trust
Who understands your business
Who understands how you do business.

Scribe(s)
Should be more than 1 person.
Records everything the audit team does
Takes copious notes
Summarizes notes at the end of each day and at
the end of the audit.
Available to explain notes at time of response.

Spokesperson
Responds to general questions.
Should be aware of the general actions of
the facility.
Should know who specifically to reach out to
for area specific questions.
May/may not be the leader/ lawyer/ owner/
manager.

INSPECTION

Agency at the Door
Never leave
the auditors
alone;
Record
everything;
Be cordial;
Do not
volunteer
information;
Only talk if
you know.

Inspection by the Guard
Check IDs
Record entry
Get business cards
Contact POC
Escort them to the audit room

POC’s Actions
Assemble response team.
Informing site | sponsor that agency is
present.
Dismiss non essential individuals
Assemble war room

Spokesperson
Identifies themselves to the audit team.
Determines the reason/scope of the audit. (not
for/cause?)
Asks audit team to sign any confidentiality agreements
etc.
Responds to general questions.
Consults with leader
Negotiates expectations with audit team.

What should you likely not include?
Abuse
audit team
Assert lack of
credibility of audit
team
Assert lack
of technical
knowledge
of audit
team
Assert lack of
competence by the
FDA

POST INSPECTION

Post Inspection Reactions
• Regulatory Response Team
• Leader
• Legal ((May become
defacto spokesperson)
• Scribe
• Regulatory (May become
defacto spokesperson)
• Quality
Smaller
companies:
• Regulatory Response Team
• Media Response Team
Larger
Companies

FAQS

Can I fire the person who reported the
Company?
No. There are specific
whistle-blower laws that
protect whistle-blowers.
You need to talk to an
attorney who can help you
determine how to work with
whistleblowers.

How can I mitigate financial
expenses?
If the matter is escalating
(litigation etc), your business is
stopped or you need to retain
counsel, see if your site has
specific insurance covering such
expenses?

How do I show a good faith effort to
comply?
Appropriate SOPs
Internal
• Training
• Retraining
• Clear communication with agency
• Self audits
• Self reporting
• external auditors
• monitors
• Making commitments
• Keeping them.
Terminate relationships with
violative contractors
External:

What shouldn’t I do?
Commit in haste
Over-commit and under deliver
Commit without assessing impact
on operations.

If there is a problem
Company understands the problem
Company has a commitment to
fixing the problem
Company has the resources to fix
the problem

WHAT SHOULD YOU LIKELY NOT DO?
Statements that anger the FDA by:
• Asserting lack of credibility
Abusing them
• Asserting lack of competence by
the FDA
Asserting lack of technical
knowledge by the FDA

Who should sign?
The manager in
charge, with the
ability to cause and
enforce changes.

Darshan Kulkarni
Synchrogenix
Ph: 302.892.4800
SLIDES MADE AVAILABLE UPON REQUEST.
@FDALawyers
Questions?

REFERENCES
Writing An Effective 483 Response
http://www.fda.gov/downloads/BiologicsBloodVaccines/
NewsEvents/WorkshopsMeetingsConferences/UCM102921.pdf
Responding to a form 483 or Warning Letter: A Practical Guide, Food and Drug Law
Journal Volume 60, Number 4, Cooper R, Fleder J (2005)
Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors FDA
Inspections of Clinical Investigators
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126553.pdf
(June 2010)

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