1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]

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Top 10 Medical Device

Citations

Regina A. BarrellFood and Drug Administration

Office of Regulatory Affairs

Office of EnforcementDivision of Compliance Management and Operations



QSIT Approach to Inspections

Level 1 – Abbreviated –

2 subsystems;

Corrective and Preventive Actions (CAPA)plus Production and Process Controls (P &

PC) or Design Controls.




Level 2 – Comprehensive –

4 major subsystems;

Management Controls, Design Controls,CAPA and P & PC.




Level 3 – Compliance Follow-Up –

Special – For Cause –

Special – Risk Based Work Plan -

As directed by inspectional guidance andelements of QSIT.




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.



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



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



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)



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)



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.



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;



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.




Number Two

21 CFR 820.198(a)

Procedures for receiving, reviewing, andevaluating 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 ortimely manner;

are not documented; or

have not been evaluated for MDR applicability.




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 Handlingprocedure states that complaints shallbe reviewed for MDR reporting per 21

CFR 803, however there are noadditional MDR procedures.



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.




Number Four

21 CFR 820.100(b)

Corrective and preventive action activitiesand/or results have not been [adequately]

documented.



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.



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.



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.



FDA Enforcement Statistics

SummaryFiscal Year 2011

Seizures 15

Injunctions 16

Warning Letters 1720

Recall Events 3640

Recalled Products 9288Debarments 16



CDRH Enforcement Statistics

SummaryFiscal Year 2011

Seizures 1

Injunctions 0

Warning Letters 175

Recall Events 1,271

Recalled Products 3,211



CDRH Seizures

By Fiscal Year 2007 - 2011

1

0

2

1

0

1

2

2007 2008 2010 2011



CDRH Injunctions

By Fiscal Year

4

1

2

00

1

2

3

4

2007 2008 2010 2011



CDRH Warning Letters

By Fiscal Year

155 152

204

175

0

25

50

75

100

125

150

175

200

225

2007 2008 2010 2011



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



Total Recall Products by CDRH


1,279

2,472 2,634

3,211

0500

1000

15002000

2500

30003500

2007 2008 2010 2011

Class I, II and III



FDA Recalls – All Classes


664 831 876

1,2711,279

2,472 2,634

3,211

0500

1000

15002000

2500

30003500

2007 2008 2010 2011

Events Products



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.



CDRH Class I Recalls –


26 1449 5045

131

334

427

0

50

100

150

200

250

300

350

400

450

2007 2008 2010 2011

Events Products



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.





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.



CDRH Class III Recalls –


98 108

74 70

132

163

92

119

0

20

40

60

80

100

120

140

160

180

2007 2008 2010 2011

Events Products



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1 Presentation 120605 Drug 100 Barrell [Compatibility Mode]