Top 10 Medical Device
Citations
Regina A. Barrell
Food and Drug Administration
Office of Regulatory Affairs
Office of Enforcement and Import Operations
Division of Enforcement
QSIT Approach to Inspections
Level 1 – Abbreviated –


2 subsystems;
Corrective and Preventive Actions (CAPA)
plus Production and Process Controls (P &
PC) or Design Controls.
QSIT Approach to Inspections
Level 2 – Comprehensive –


4 major subsystems;
Management Controls, Design Controls,
CAPA and P & PC.
QSIT Approach to Inspections
Level 3 – Compliance Follow-Up –
Special – For Cause –
Special – Risk Based Work Plan As directed by inspectional guidance and
elements of QSIT.
QSIT Approach to Inspections
Compliance Follow-Up, For Cause and
Risk Based Work Plan are dictated by the
previous FDA-483 findings and other
regulatory information and may differ from
the typical QSIT approach.
2012
1. 820.100(a) – Corrective and Preventive
Action (Procedures)
2. 820.198(a) – Complaint procedures
3. 803.17 – Written MDR procedures
4. 820.100(b) – Corrective and Preventive
Action (Documentation)
5. 820.50 – Purchasing Controls
2012
6. 820.75(a) – Process validation
7. 820.90(a) – Control of non-conforming product
8. 820.30 (i) – Design change procedures
9. 820.198 (c) – Complaint investigation
10. 820.181 – Device master record not
maintained
Total Turbo Citations
vs.
2012 Citations
Total
2012
1
820.100(a)
820.100(a)
2
803.17
820.198(a)
3
820.100(b)
803.17
4
820.198(a)
820.100(b)
5
820.75(a)
820.50
Total Turbo Citations
vs.
2012 Citations
Total
2012
6
820.22
820.75(a)
7
820.22
820.90(a)
8
820.30(i)
820.30(i)
9
820.50
820.198(c)
10
820.30(a)
820.181
TOP FIVE FDA 483 CITATIONS
FOR MEDICAL DEVICE FIRMS
Number One
21 CFR 820.100(a)
Procedures for corrective and preventive
action have not been [adequately]
established.
21 CFR 820.100(a)
For example:

Failure to analyze processes, service records,
quality audit reports, complaints, returned
product, and other sources of quality data to
identify existing and potential causes of
nonconforming product;
21 CFR 820.100(a) contd.
Cause of nonconformities relating to
product, processes and the quality
system are not investigated;
Actions needed to correct and
prevent recurrence of nonconforming
product or other quality problems are
not identified.
TOP FIVE FDA 483 CITATIONS
FOR MEDICAL DEVICE FIRMS
Number Two
21 CFR 820.198(a)
Procedures for receiving, reviewing, and
evaluating complaints by a formally
designated unit have not been
[adequately] established.
21 CFR 820.198(a)
For example:
Complaints are not processed in a uniform or
timely manner;
are not documented; or
have not been evaluated for MDR applicability.
TOP FIVE FDA 483 CITATIONS
FOR MEDICAL DEVICE FIRMS
Number Three
21 CFR 803.17
Written MDR procedures have not been
[developed] [maintained] [implemented].
21 CFR 803.17
For example:
Your firm’s Complaint Handling
procedure states that complaints shall
be reviewed for MDR reporting per 21
CFR 803, however there are no
additional MDR procedures.
21 CFR 803.17 contd.
For example:

Your procedure does not contain a
standardized process for determining when
an event meets the criteria for MDR. There
are no instructions for how your firm will
evaluate information about an event to make
MDR reportability determinations in a timely
manner.
TOP FIVE FDA 483 CITATIONS
FOR MEDICAL DEVICE FIRMS
Number Four
21 CFR 820.100(b)
Corrective and preventive action activities
and/or results have not been [adequately]
documented.
TOP FIVE FDA 483 CITATIONS
FOR MEDICAL DEVICE FIRMS
Number Five
21 CFR 820.50
Procedures to ensure that all purchased or
otherwise received product and services
conform to specified requirements have
not been [adequately] established.
21 CFR 820.50
For example:

Of 11 supplier records reviewed, 4
were not evaluated or included on
your firm’s approved supplier list.
21 CFR 820.50 contd.
For example:

Your supplier, which was used to fill
ampoules, was disqualified due to
quality issues but was left on your
approved suppliers list because the
supplier was still approved for other
services.
FDA Enforcement Statistics
Summary
Fiscal Year 2012
Seizures
8
Injunctions
17
Warning Letters
4,882
Recall Events
4,075
Recalled Products
9,469
Debarments
20
CDRH Enforcement Statistics
Summary
Fiscal Year 2012
Seizures
1
Injunctions
2
Warning Letters
210
Recall Events
1,190
Recalled Products
2,475
CDRH Seizures
By Fiscal Year
2
2
1
1
1
1
0
0
2007
2008
2010
2011
2012
CDRH Injunctions
By Fiscal Year
4
4
3
2
2
2
1
1
0
0
2007
2008
2010
2011
2012
CDRH Warning Letters
By Fiscal Year
225
200
175
210
204
175
155
152
2007
2008
150
125
100
75
50
25
0
2010
2011
2012
Total Recall Events - CDRH
Fiscal Year 2007 - 2012
1400
1,271
1200
1000
800
831
876
2008
2010
1,190
664
600
400
200
0
2007
2011
Class I, II and III
2012
Total Recall Products - CDRH
Fiscal Year 2007 - 2012
3500
3,211
3000
2,472
2500
2,634
2,475
2000
1500
1,279
1000
500
0
2007
2008
2010
2011
Class I, II and III
2012
CDRH Recalls – All Classes
Fiscal Year 2007 - 2012
3500
3,211
3000
2,472
2500
2,634
2,475
2000
1500
1000
1,279
664
1,271
831
876
2008
2010
1,190
500
0
2007
Events
2011
2012
Products
Recalls: Definition of Class I
Class I recall: a situation in which there is
a reasonable probability that the use of or
exposure to a violative product will cause
serious adverse health consequences or
death.
CDRH Class I Recalls –
Fiscal Year 2007 - 2012
450
400
350
300
250
200
150
100
50
0
427
334
131
26
45
2007
14
2008
124
49
50
57
2010
2011
2012
Events
Products
Recalls: Definition of Class II
Class II recall: a situation in which use of
or exposure to a violative product may
cause temporary or medically reversible
adverse health consequences or where
the probability of serious adverse health
consequences is remote.
CDRH Class II Recalls –
Fiscal Year 2007 - 2012
3000
2,665
2500
2,178
2,208
2,210
2000
1500
1000
1,151
1,102
540
709
753
2008
2010
1,043
500
0
2007
Events
2011
2012
Products
Recalls: Definition of Class III
Class III recall: a situation in which use of
or exposure to a violative product is not
likely to cause adverse health
consequences.
CDRH Class III Recalls –
Fiscal Year 2007 - 2012
180
160
140
120
100
80
60
40
20
0
163
141
132
98
2007
119
108
92
2008
90
74
70
2010
2011
Events
2012
Products
Root-Cause Categories
FY 2010 – FY 2012
11%
19%
15%
49%
6%
Design
Process Control
Packaging/Labeling
Change Control
Material/Component
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