Enforcement Basics: What to do When the
Government Shows Up at Your Door
Gary Bird, President, PharmaConsult-US
Lori Hirsch, Managing Counsel, Merck & Co., Inc.
Enforcement
Litigation and
Compliance
Washington, DC
December 9-10,
2015
LCDR Collins Mason, Director, Compliance Branch, Baltimore
District, FDA
Amra Racic, Principal Regulatory Affairs Policy and Advocacy
Specialist, Medtronic PLC
Moderated by Nancy Singer, President, Compliance-Alliance, LLC
Enforcement Basics:
What to do when the government
shows up at your door.
Panelists:
Gary Bird, PharmaConsult-US
Lori Hirsch, Merck & Co., Inc.
LCDR Collins Mason, FDA
Amra Racic, Medtronic PLC
Moderator
Nancy Singer, Compliance-Alliance
2
Agenda
• Overview of FDA’s Inspection Process –LCDR Collins
Mason, Supervisor Investigator, FDA Baltimore District
Office
• Interactive Moderated Panel Discussion
• Opportunity to Ask Questions
3
Who are we: General
overview of FDA’s BLT-DO.
Collins M Mason
LCDR, USPHS
SCSO, Baltimore District (BLT-DO)
Food and Drug Administration (FDA)
4
5
Baltimore District (BLT-DO)
BLT-DO
BLT-IB
BLT-CB
DO
G1-Foods
G2-DMTImports/All
G3Biologics
MGN/All
G4-RCH-All
BLT-Admin
Domestics
G5-NOVAAll
G6-Med
Dev &
Drugs
RCH-RP
CST x 1
RNK-RP
CSO x 8-10
G7-SEVAImports/All
GDUFA
Imports
6
BLT-IB Branch Make-up
 Branch Director (DIB): Constance Richard-Math
 Deputy Director (DDIB): LCDR Cornelius Brown III
 8 x Supervisory Consumer Safety Officers (SCSOs)
 8 Groups
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1 Import
1 GDUFA
2 Imp/Dom
5 Dom)
 District Office
 4 groups
 Resident Post
 4 groups
7
BLT-IB Branch Make-up CTD.
 Resident Posts (RPs)
 4 groups
 6 locations
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BLT-DO
Baltimore District Office
DMT-RP Dundalk, MD
MGN-RP Morgantown, WV
NOVA-RP Northern Virginia/Falls Church, VA
RCH-RP Richmond, VA
RNK-RP Roanoke, VA
SEVA-RP Southeastern Virginia/Portsmouth, VA
 Personnel makeup varies at RPs & DO
 Typical
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Consumer Safety Officers/ (CSOs)/Investigators 10/group
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Conduct Inspections
8-10 per RP or Group
Consumer Safety Technicians (CST)
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Provide admin & other support
1/RP or Group
8
BLT-IB Branch Make-up CTD.
 Other IB Personnel
 Consumer Complaint Coordinator
 Handle complaints
 Program Support Specialists (PSS)
 Multiple tasks
 Official Establishment Inventory (OEI) Coordinator
 Manage Inventory of regulated industry

Important operational changes
 Out of Business
 Registrations
 NOEI
 Profile changes
 Other related tasks
9
Work Products & Output
 Inspections-EIR
 Defn: a careful, critical, official examination of a facility to
determine its compliance with laws administered by FDA
 Domestic & Foreign
 Samples- Collection Report
 Domestic, Foreign, Imports
 Physical Product or
 Paperwork (documentary sample)
 Perform Recall Activities
 Effectiveness checks - Form 3177
 Attachment B Information
10
Work Products & Output CTD.
 Perform Investigations - Memo
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Consumer Complaint follow-ups
Injury and Adverse Reactions
Foodborne Outbreaks
Tampering
Health Fraud
Disasters
Change in Business Operations
 Perform Field Examinations
 Review of physical product
 Surveillance
 Compliance
 For cause …apparent violation
 Entry Review/Imports Operations
 Referrals from & to the States, OCI
11
IB Source of Operations
 ORA/BLT-DO Workplan
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Cycle based with factors
depends on center/program area/risks
ORA Performance Goals
Workplan Assignments
Ad Hoc Assignments
 Diverse sources (see below)
 Assignments from the Centers
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RTE cold cuts/swabbing
Infant & Dried Cereal
Egg Farms/Hatchery
Compounding Pharmacy
 Consumer Complaints
 Recalls
 Referrals from State, OCI
12
FDA Centers as Ops source
 CFSAN
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 Accounts for majority of work
CDER
CDRH
CBER
CVM
CTP
 Conducts it owns inspections
13
FY15 Based Data Sample
Industry Profile
BALTIMORE DISTRICT OEI - ACTIVE FIRMS
TOTAL - 6,149
419
7%
266
4%
645
10%
1944
32%
2875
47%
FOODS
MEDICAL DEVICES
HUMAN DRUGS
BIOLOGICS
ANIMAL PRODUCTS
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Programs covered by IB
(foreign/domestic)
 CFSAN & Food Safety
 Fish and Fishery Products
 Interstate Travel Program
 Veterinary Medicine
 Feed
 CVM
 BSE/Ruminant Feed Ban
 Medicated Feed
 CDRH
 Medical Devices
 Mammography/X-Ray
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Programs covered by IB
(foreign/domestic) CTD.
 Drugs
 GMP
 Pre-approval)
 Biologics
 Blood Banks,
 Plasma
 Human Tissue
 Bioresearch Monitoring Program (BIMO)
 Imports
 Tobacco
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Purpose and Types of Insp. (EI)
 Purpose defined by
 Program Assignment Code (PAC)
 Drug, medical gas, medicated feed, general food
 Assignment Specs
 Surveillance vs compliance
 Cycle
 Abbreviated, comprehensive
 Types of EIs
 Comprehensive
 Coverage of everything having to do with product(s) selected
to determine compliance
 Directed/Abbreviated
 Coverage of specific areas to a depth described in
assignment, in CP, or by SCSO
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Stages of an Inspection?
 Prepping
 Getting ready for the Inspection/EI
 Executing
 Conducting the Inspection/EI
 Reporting
 Reporting the results of an Inspection/EI
18
Prepping for an EI
 Review
 Previous inspections, CFRs, Compliance Programs, &
Guidance documents
 Assignment (including FACTS assignment)
 IOM (including subchapters 5.4-5.10)
 Proprietary FDA databases (registration, listing,
complaints)
 Talk to Agency personnel
 CSO who performed previous EI,
 SCSO
 District specialist
 Center contact
 Preannounce if necessary
 CDRH, BIMO
 Use Agency’s resources appropriately
 Prep time/time at firm is an agency resource
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Executing: General
 Opening Interview
 Present Credentials
 Issue FDA 482 & other pertinent documents
 Discussion with staff
 Start Inspecting
 Request documents & ask questions
 Floor plan
 Product list
 What’s being manufactured?

Select process/product to cover
 Tour facility/Walkthrough
 Familiarize yourself & verify the “live operation”
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To plan/modify inspectional strategy
Develop/modify inspectional plan
Executing: Documenting
 Obtain Information from knowledgeable persons
 Interview/observe personnel/process in action i.e. Live
 Avoid releasing confidential information
 Reassure the firm collected info is proprietary
 Maintain professionalism
 Keep the firm informed of findings (no surprises)
 In real time &
 During daily closing discussions
21
Reporting
 Establishment Inspection Report (EIR)
 Sample Sections
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Summary
Administrative Data
History
Manufacturing/Design Operations
Manufacturing Codes
Complaints
Recall Procedures
Objectionable Conditions & Management Response
Refusals
General Discussion with Management
Voluntary Corrections
Exhibits Collected
Attachments
QUESTIONS??
Please contact the following:
Constance Richard-Math
Connie.Richard-Math@fda.hhs.gov
or
Cornelius Brown III, DIB, LCDR
Cornelius.brown1@fda.hhs.gov
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The End
24
Interactive Moderated Panel Discuss
1. Panelists introduce themselves
2. Attendees participate in an interactive discussion
3. Opportunity to ask questions
25
Who are we?
 Collins Mason
 Nancy Singer
 Gary Bird, Ph.D.
 Lori Hirsch
 Amra Racic
26
Process
 Form small groups of 5-6 people.
 Briefly introduce yourself:
 State your name, title and number of years at your
organization.
 Identify the chairperson:
 Person with the first letter of the last name closest to A.
 From each slide describing a scenario, out of the four options
listed, select ONLY ONE. (It should be the best option or the
one you would do first.)
 Reach consensus among the group members. If not, the
chairperson chooses.
 If you finish an individual question, discuss the extra credit
question that will be handed out.
27
Scenario 1
The FDA investigator refuses to provide a daily briefing in a
medical device inspection. You explain that there is a
provision in the IOM that states the requirement for providing
a daily briefing in a device inspection. The investigator still
refuses. What do you do?
a. Accept his decision as you don’t want to alienate the
investigator.
b. Call the investigator’s supervisor.
c. Mention the investigator’s failure to provide the daily
briefing in your response to the 483.
d. Call your lawyer and ask him/her to talk to the investigator.
28
Scenario 2
You company has been in business for 15 years. You
manufacture a low risk device, and your company has not
received any adverse incidents that would have required you
to file an MDR. You discover that one of your employees has
falsified information during complaint investigations in order to
clear up the backlog of complaints. You correct the situation.
What do you do?
a. Write a corrective action plan, and then schedule a meeting
with the District Director to discuss it.
b. Implement the corrective action plan and bring it up during
your next inspection.
c. Put the issue into your CAPA system and don’t mention it to
the FDA.
d. Call the Office of Compliance in FDA headquarters and
explain the situation.
29
Scenario 3
The FDA investigator is new and writes numerous incorrect
items on the 483. After explaining that you believe the items
are not correct, you
a. Call his supervisor and explain the situation.
b. Accept the 483 observations and provide annotations
stating “Under consideration.”
c. Acknowledge receipt of the 483 observations and write a
comprehensive explanation in the response to the 483
explaining why you disagree with the observations.
d. Ask your company lawyer to talk to the investigator.
30
Scenario 4
Your company is located in Hamburg, Germany. A man
arrives at your plant. He says he is from the FDA, shows his
credentials, but does not provide a FDA 482. What do you
do?
a. Let him in.
b. Ask him to call his office and have them fax the form to
you.
c. Call FDA headquarter and ask for their advice.
d. Call the local authorities and have him arrested.
31
Scenario 5
You are the Quality VP. Your firm recently received a warning
letter. You are implementing the corrective action plan that you
provided in your response to the warning letter. A new FDA
District Director has taken over. After she has been there for a
several months, describe which of the following actions you
would take in regard to getting acquainted.
a. You schedule an appointment to explain that your firm is
committed to taking corrective action.
b. You schedule an appointment and bring the company
president along to show that your firm is committed to taking
corrective action.
c. You do not schedule an appointment, but look for an
opportunity, such as an educational event, to get acquainted.
d. You want to keep a low profile, so you do not reach out to her.
32
Scenario 6
The FDA investigator takes out his camera and begins to take
photographs of your operations. You
a. Say that he can’t because you are obligated to operate in a
state of control and follow your Quality System
procedures, which doe not allow outsiders to take pictures.
b. Call your lawyer.
c. Call FDA’s Chief Counsel’s Office.
d. Allow the investigator to take the pictures.
33
Develop Your Solution
The next set of scenario are challenging situations that might
occur during an FDA inspection. For each situation, groups
should determine what they would say to the investigator.
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Question I
The FDA asked you for a specific record and, when
you look in the file, it is missing or incomplete.
35
Question II
One of your firm’s employees provides incorrect
information to the FDA investigator.
36
Question III
The FDA investigator asks for a specific document,
but the document doesn’t seem to satisfy the
investigator’s concern.
37
Question IV
The investigator asks you questions about top
management’s commitment to quality and whether
you have the required resources to do your job.
38
Extra Credit Scenario
Your executive management refuses to provide adequate
resources to fix the observations found by your internal
auditor during her recent audit. They say, “During the last
inspection, the investigator did not cite us for these
deficiencies, so why should we spend the money now?”
How would you respond?
39
Group Discussion
In your small group, discuss might be the biggest challenge
that companies have in regard to FDA inspections. Once you
get agreement, raise your hand and you can ask the panel to
comment.
40