1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
-
Upload
ciprian-alex-sky -
Category
Documents
-
view
218 -
download
0
Transcript of 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 1/36
Top 10 Medical Device
Citations
Regina A. BarrellFood and Drug Administration
Office of Regulatory Affairs
Office of EnforcementDivision of Compliance Management and Operations
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 2/36
QSIT Approach to Inspections
Level 1 – Abbreviated –
2 subsystems;
Corrective and Preventive Actions (CAPA)plus Production and Process Controls (P &
PC) or Design Controls.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 3/36
QSIT Approach to Inspections
Level 2 – Comprehensive –
4 major subsystems;
Management Controls, Design Controls,CAPA and P & PC.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 4/36
QSIT Approach to Inspections
Level 3 – Compliance Follow-Up –
Special – For Cause –
Special – Risk Based Work Plan -
As directed by inspectional guidance andelements of QSIT.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 5/36
QSIT Approach to Inspections
Compliance Follow-Up, For Cause andRisk Based Work Plan are dictated by the
previous FDA-483 findings and otherregulatory information and may differ fromthe typical QSIT approach.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 6/36
2011
1. 820.100(a) – Corrective and Preventive
Action (Procedures)
2. 820.198(a) – Complaint procedures
3. 803.17 – Written MDR procedures4. 820.100(b) – Corrective and Preventive
Action (Documentation)
5. 820.75(a) – Process Validation
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 7/36
2011
6. 820.181 – Device Master Record
7. 820.50 – Purchasing Controls
8. 820.90 (a) – Control of non-conforming
product
9. 820.22 – Quality Audit procedures
10. 820.30 (i) – Design Change procedures
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 8/36
Total Turbo Citations
vs.2011 Citations
Total 2011
1 820.100(a) 820.100(a)
2 803.17 820.198(a)
3 820.198(a) 803.17
4 820.100(b) 820.100(b)
5 820.75(a) 820.75(a)
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 9/36
Total Turbo Citations
vs.2011 Citations
Total 2011
6 820.22 820.181
7 820.22 820.50
8 820.30(a) 820.90(a)
9 820.30(i) 820.22
10 820.50 820.30(i)
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 10/36
TOP FIVE FDA 483 CITATIONSFOR MEDICAL DEVICE FIRMS
Number One
21 CFR 820.100(a)
Procedures for corrective and preventiveaction have not been [adequately]
established.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 11/36
21 CFR 820.100(a)
For example:
Failure to analyze processes, service records,quality audit reports, complaints, returnedproduct, and other sources of quality data toidentify existing and potential causes ofnonconforming product;
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 12/36
21 CFR 820.100(a) contd.
Cause of nonconformities relating to
product, processes and the qualitysystem are not investigated;
Actions needed to correct andprevent recurrence of nonconforming
product or other quality problems arenot identified.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 13/36
TOP FIVE FDA 483 CITATIONSFOR MEDICAL DEVICE FIRMS
Number Two
21 CFR 820.198(a)
Procedures for receiving, reviewing, andevaluating complaints by a formally
designated unit have not been[adequately] established.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 14/36
21 CFR 820.198(a)
For example:
Complaints are not processed in a uniform ortimely manner;
are not documented; or
have not been evaluated for MDR applicability.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 15/36
TOP FIVE FDA 483 CITATIONSFOR MEDICAL DEVICE FIRMS
Number Three
21 CFR 803.17
Written MDR procedures have not been[developed] [maintained] [implemented].
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 16/36
21 CFR 803.17
For example:
Your firm’s Complaint Handlingprocedure states that complaints shallbe reviewed for MDR reporting per 21
CFR 803, however there are noadditional MDR procedures.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 17/36
21 CFR 803.17 contd.
For example:
Your procedure does not contain a
standardized process for determining whenan event meets the criteria for MDR. Thereare no instructions for how your firm will
evaluate information about an event to makeMDR reportability determinations in a timelymanner.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 18/36
TOP FIVE FDA 483 CITATIONSFOR MEDICAL DEVICE FIRMS
Number Four
21 CFR 820.100(b)
Corrective and preventive action activitiesand/or results have not been [adequately]
documented.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 19/36
TOP FIVE FDA 483 CITATIONS
FOR MEDICAL DEVICE FIRMS
Number Five
21 CFR 820.75(a)
A process whose results cannot be fullyverified by subsequent inspection and test
has not been [adequately] validatedaccording to established procedures.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 20/36
21 CFR 820.75(a)
For example:
Storage conditions were not definedor monitored for the chemicalindicators used in the Ethylene
Oxide validation study as well asduring routine processing.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 21/36
21 CFR 820.75(a) contd.
For example:
There is no process validation studyfor the radio frequency weldingprocess used to weld flanges onto
the bladder that is a component ofthe X device.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 22/36
FDA Enforcement Statistics
SummaryFiscal Year 2011
Seizures 15
Injunctions 16
Warning Letters 1720
Recall Events 3640
Recalled Products 9288Debarments 16
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 23/36
CDRH Enforcement Statistics
SummaryFiscal Year 2011
Seizures 1
Injunctions 0
Warning Letters 175
Recall Events 1,271
Recalled Products 3,211
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 24/36
CDRH Seizures
By Fiscal Year 2007 - 2011
1
0
2
1
0
1
2
2007 2008 2010 2011
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 25/36
CDRH Injunctions
By Fiscal Year
4
1
2
00
1
2
3
4
2007 2008 2010 2011
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 26/36
CDRH Warning Letters
By Fiscal Year
155 152
204
175
0
25
50
75
100
125
150
175
200
225
2007 2008 2010 2011
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 27/36
Total Recall Events by CDRH
Fiscal Year 2007 - 2011
664
831 876
1,271
0200
400
600800
1000
1200
1400
2007 2008 2010 2011
Class I, II and III
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 28/36
Total Recall Products by CDRH
Fiscal Year 2007 - 2011
1,279
2,472 2,634
3,211
0500
1000
15002000
2500
30003500
2007 2008 2010 2011
Class I, II and III
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 29/36
FDA Recalls – All Classes
Fiscal Year 2007 - 2011
664 831 876
1,2711,279
2,472 2,634
3,211
0500
1000
15002000
2500
30003500
2007 2008 2010 2011
Events Products
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 30/36
Recalls: Definition of Class I
Class I recall: a situation in which there is
a reasonable probability that the use of orexposure to a violative product will causeserious adverse health consequences or
death.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 31/36
CDRH Class I Recalls –
Fiscal Year 2007 - 2011
26 1449 5045
131
334
427
0
50
100
150
200
250
300
350
400
450
2007 2008 2010 2011
Events Products
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 32/36
Recalls: Definition of Class IIClass II recall: a situation in which use of
or exposure to a violative product maycause temporary or medically reversibleadverse health consequences or where
the probability of serious adverse healthconsequences is remote.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 33/36
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 34/36
Recalls: Definition of Class IIIClass III recall: a situation in which use of
or exposure to a violative product is notlikely to cause adverse healthconsequences.
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 35/36
CDRH Class III Recalls –
Fiscal Year 2007 - 2011
98 108
74 70
132
163
92
119
0
20
40
60
80
100
120
140
160
180
2007 2008 2010 2011
Events Products
8/12/2019 1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]
http://slidepdf.com/reader/full/1-presentation-120605-drug-100-barrell-compatibility-mode 36/36
QUESTIONS??