Top 10 Medical Device

Citations

Regina A. BarrellFood and Drug Administration

Office of Regulatory AffairsOffice of Enforcement

Division 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.

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.

2011

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. 820.75(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 Citationsvs.

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 Citationsvs.

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 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 820.75(a)

A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures.

21 CFR 820.75(a)

For example:

� Storage conditions were not defined or monitored for the chemical indicators used in the Ethylene Oxide validation study as well as during routine processing.

21 CFR 820.75(a) contd.

For example:

� There is no process validation study for the radio frequency welding process used to weld flanges onto the bladder that is a component of the X device.

FDA Enforcement Statistics

Summary

Fiscal Year 2011

Seizures 15

Injunctions 16

Warning Letters 1720

Recall Events 3640

Recalled Products 9288

Debarments 16

CDRH Enforcement Statistics

Summary

Fiscal 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 CDRHFiscal Year 2007 - 2011

664

831 876

1,271

0

200

400

600

800

1000

1200

1400

2007 2008 2010 2011

Class I, II and III

Total Recall Products by CDRHFiscal Year 2007 - 2011

1,279

2,4722,634

3,211

0

500

1000

1500

2000

2500

3000

3500

2007 2008 2010 2011

Class I, II and III

FDA Recalls – All ClassesFiscal Year 2007 - 2011

664831 876

1,2711,279

2,4722,634

3,211

0

500

1000

1500

2000

2500

3000

3500

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 or exposure to a violative product will cause serious adverse health consequences or death.

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

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 - 2011

540709 753

1,1511,102

2,178 2,208

2,665

0

500

1000

1500

2000

2500

3000

2007 2008 2010 2011

Events 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 - 2011

98108

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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