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Top 10 Medical Top 10 Medical Device Citations Device Citations Regina A. Barrell Regina A. Barrell Food and Drug Administration Food and Drug Administration Office of Regulatory Affairs Office of Regulatory Affairs Office of Enforcement and Import Office of Enforcement and Import Operations Operations Division of Enforcement Division of Enforcement

Top 10 Medical Device Citations Regina A. Barrell Food and Drug Administration Office of Regulatory Affairs Office of Enforcement and Import Operations

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Top 10 Medical Device Top 10 Medical Device CitationsCitations

Regina A. BarrellRegina A. BarrellFood and Drug AdministrationFood and Drug Administration

Office of Regulatory AffairsOffice of Regulatory AffairsOffice of Enforcement and Import OperationsOffice of Enforcement and Import Operations

Division of EnforcementDivision of Enforcement

QSIT Approach to InspectionsQSIT Approach to Inspections

Level 1 – Abbreviated –Level 1 – Abbreviated –

2 subsystems;2 subsystems;

Corrective and Preventive Actions Corrective and Preventive Actions (CAPA) (CAPA) plus Production and Process plus Production and Process Controls (P & Controls (P & PC) PC) oror Design Controls. Design Controls.

QSIT Approach to InspectionsQSIT Approach to Inspections

Level 2 – Comprehensive – Level 2 – Comprehensive –

4 major subsystems;4 major subsystems;

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

QSIT Approach to InspectionsQSIT Approach to Inspections

Level 3 – Compliance Follow-Up –Level 3 – Compliance Follow-Up –

Special – For Cause – Special – For Cause –

Special – Risk Based Work Plan - Special – Risk Based Work Plan -

As directed by inspectional guidance and As directed by inspectional guidance and elements of QSIT.elements of QSIT.

QSIT Approach to InspectionsQSIT Approach to Inspections

Compliance Follow-Up, For Cause and Compliance Follow-Up, For Cause and Risk Based Work Plan are dictated by the Risk Based Work Plan are dictated by the previous FDA-483 findings and other previous FDA-483 findings and other regulatory information and may differ from regulatory information and may differ from the typical QSIT approach. the typical QSIT approach.

20122012

1.1. 820.100(a) – Corrective and Preventive 820.100(a) – Corrective and Preventive Action (Procedures)Action (Procedures)

2.2. 820.198(a) – Complaint procedures820.198(a) – Complaint procedures

3.3. 803.17 – Written MDR procedures 803.17 – Written MDR procedures

4.4. 820.100(b) – Corrective and Preventive 820.100(b) – Corrective and Preventive Action (Documentation)Action (Documentation)

5.5. 820.50 – Purchasing Controls820.50 – Purchasing Controls

20122012

6.6. 820.75(a) – Process validation820.75(a) – Process validation

7.7. 820.90(a) – Control of non-conforming product820.90(a) – Control of non-conforming product

8.8. 820.30 (i) – Design change procedures 820.30 (i) – Design change procedures

9.9. 820.198 (c) – Complaint investigation820.198 (c) – Complaint investigation

10.10. 820.181 – Device master record not 820.181 – Device master record not

maintained maintained

Total Turbo CitationsTotal Turbo Citationsvs.vs.

2012 Citations2012 CitationsTotalTotal 20122012

11 820.100(a)820.100(a) 820.100(a)820.100(a)

22 803.17803.17 820.198(a)820.198(a)

33 820.100(b)820.100(b) 803.17803.17

44 820.198(a)820.198(a) 820.100(b)820.100(b)

55 820.75(a)820.75(a) 820.50820.50

Total Turbo CitationsTotal Turbo Citationsvs. vs.

2012 Citations2012 CitationsTotalTotal 20122012

66 820.22820.22 820.75(a)820.75(a)

77 820.22820.22 820.90(a)820.90(a)

88 820.30(i)820.30(i) 820.30(i)820.30(i)

99 820.50820.50 820.198(c)820.198(c)

1010 820.30(a)820.30(a) 820.181820.181

TOP FIVE FDA 483 CITATIONS TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMSFOR MEDICAL DEVICE FIRMS

Number OneNumber One

21 CFR 820.100(a)21 CFR 820.100(a)

Procedures for corrective and preventive Procedures for corrective and preventive action have not been [adequately] action have not been [adequately] established. established.

21 CFR 820.100(a)21 CFR 820.100(a)

For example: For example:

Failure to analyze processes, service records, Failure to analyze processes, service records, quality audit reports, complaints, returned quality audit reports, complaints, returned product, and other sources of quality data to product, and other sources of quality data to identify existing and potential causes of identify existing and potential causes of nonconforming product; nonconforming product;

21 CFR 820.100(a) contd.21 CFR 820.100(a) contd.

Cause of nonconformities relating to Cause of nonconformities relating to product, processes and the quality product, processes and the quality system are not investigated;system are not investigated;

Actions needed to correct and Actions needed to correct and prevent recurrence of nonconforming prevent recurrence of nonconforming product or other quality problems are product or other quality problems are not identified.not identified.

TOP FIVE FDA 483 CITATIONS TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMSFOR MEDICAL DEVICE FIRMS

Number TwoNumber Two

21 CFR 820.198(a)21 CFR 820.198(a)

Procedures for receiving, reviewing, and Procedures for receiving, reviewing, and evaluating complaints by a formally evaluating complaints by a formally designated unit have not been designated unit have not been [adequately] established. [adequately] established.

21 CFR 820.198(a)21 CFR 820.198(a)

For example:For example:

Complaints are not processed in a uniform or Complaints are not processed in a uniform or timely manner;timely manner;

are not documented; or are not documented; or

have not been evaluated for MDR applicability.have not been evaluated for MDR applicability.

TOP FIVE FDA 483 CITATIONS TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMSFOR MEDICAL DEVICE FIRMS

Number ThreeNumber Three

21 CFR 803.1721 CFR 803.17

Written MDR procedures have not been Written MDR procedures have not been [developed] [maintained] [implemented].[developed] [maintained] [implemented].

21 CFR 803.1721 CFR 803.17

For example:For example:

Your firm’s Complaint Handling Your firm’s Complaint Handling procedure states that complaints shall procedure states that complaints shall be reviewed for MDR reporting per 21 be reviewed for MDR reporting per 21 CFR 803, however there are no CFR 803, however there are no additional MDR procedures.additional MDR procedures.

21 CFR 803.17 contd.21 CFR 803.17 contd.

For example:For example:

Your procedure does not contain a Your procedure does not contain a standardized process for determining when standardized process for determining when an event meets the criteria for MDR. There an event meets the criteria for MDR. There are no instructions for how your firm will are no instructions for how your firm will evaluate information about an event to make evaluate information about an event to make MDR reportability determinations in a timely MDR reportability determinations in a timely manner.manner.

TOP FIVE FDA 483 CITATIONS TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMSFOR MEDICAL DEVICE FIRMS

Number FourNumber Four

21 CFR 820.100(b)21 CFR 820.100(b)

Corrective and preventive action activities Corrective and preventive action activities and/or results have not been [adequately] and/or results have not been [adequately] documented.documented.

TOP FIVE FDA 483 CITATIONS TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMSFOR MEDICAL DEVICE FIRMS

Number FiveNumber Five

21 CFR 820.5021 CFR 820.50

Procedures to ensure that all purchased or Procedures to ensure that all purchased or otherwise received product and services otherwise received product and services conform to specified requirements have conform to specified requirements have not been [adequately] established. not been [adequately] established.

21 CFR 820.5021 CFR 820.50

For example:For example:

Of 11 supplier records reviewed, 4 Of 11 supplier records reviewed, 4 were not evaluated or included on were not evaluated or included on your firm’s approved supplier list.your firm’s approved supplier list.

21 CFR 820.50 contd.21 CFR 820.50 contd.

For exampleFor example::

Your supplier, which was used to fill Your supplier, which was used to fill ampoules, was disqualified due to ampoules, was disqualified due to quality issues but was left on your quality issues but was left on your approved suppliers list because the approved suppliers list because the supplier was still approved for other supplier was still approved for other services.services.

FDA Enforcement StatisticsFDA Enforcement StatisticsSummarySummary

Fiscal Year 2012Fiscal Year 2012

SeizuresSeizures 88

InjunctionsInjunctions 1717

Warning LettersWarning Letters 4,8824,882

Recall EventsRecall Events 4,0754,075

Recalled ProductsRecalled Products 9,4699,469

DebarmentsDebarments 2020

CDRH Enforcement StatisticsCDRH Enforcement StatisticsSummarySummary

Fiscal Year 2012Fiscal Year 2012

SeizuresSeizures 11

InjunctionsInjunctions 22

Warning LettersWarning Letters 210210

Recall EventsRecall Events 1,1901,190

Recalled ProductsRecalled Products 2,4752,475

CDRH Seizures CDRH Seizures By Fiscal Year By Fiscal Year

1

0

2

1 1

0

1

2

2007 2008 2010 2011 2012

CDRH InjunctionsCDRH InjunctionsBy Fiscal YearBy Fiscal Year

4

1

2

0

2

0

1

2

3

4

2007 2008 2010 2011 2012

CDRH Warning LettersCDRH Warning LettersBy Fiscal YearBy Fiscal Year

155 152

204

175

210

0

25

50

75

100

125

150

175

200

225

2007 2008 2010 2011 2012

Total Recall Events - CDRHTotal Recall Events - CDRHFiscal Year 2007 - 2012Fiscal Year 2007 - 2012

664

831 876

1,2711,190

0

200

400

600

800

1000

1200

1400

2007 2008 2010 2011 2012

Class I, II and III

Total Recall Products - CDRHTotal Recall Products - CDRHFiscal Year 2007 - 2012Fiscal Year 2007 - 2012

1,279

2,472 2,634

3,211

2,475

0

500

1000

1500

2000

2500

3000

3500

2007 2008 2010 2011 2012

Class I, II and III

CDRH Recalls – All ClassesCDRH Recalls – All ClassesFiscal Year 2007 - 2012Fiscal Year 2007 - 2012

664 831 8761,271 1,1901,279

2,472 2,634

3,211

2,475

0

500

1000

1500

2000

2500

3000

3500

2007 2008 2010 2011 2012

Events Products

Recalls: Definition of Class IRecalls: Definition of Class I

Class I recall: a situation in which there is Class I recall: a situation in which there is a reasonable probability that the use of or a reasonable probability that the use of or exposure to a violative product will cause exposure to a violative product will cause serious adverse health consequences or serious adverse health consequences or death.death.

CDRH Class I Recalls – CDRH Class I Recalls – Fiscal Year 2007 - 2012Fiscal Year 2007 - 2012

26 1449 50 5745

131

334

427

124

050

100150200250300350400450

2007 2008 2010 2011 2012

Events Products

Recalls: Definition of Class IIRecalls: Definition of Class II

Class II recall: a situation in which use of Class II recall: a situation in which use of or exposure to a violative product may or exposure to a violative product may cause temporary or medically reversible cause temporary or medically reversible adverse health consequences or where adverse health consequences or where the probability of serious adverse health the probability of serious adverse health consequences is remote. consequences is remote.

CDRH Class II Recalls – CDRH Class II Recalls – Fiscal Year 2007 - 2012Fiscal Year 2007 - 2012

540709 753

1,151 1,0431,102

2,178 2,208

2,665

2,210

0

500

1000

1500

2000

2500

3000

2007 2008 2010 2011 2012

Events Products

Recalls: Definition of Class IIIRecalls: Definition of Class III

Class III recall: a situation in which use of Class III recall: a situation in which use of or exposure to a violative product is not or exposure to a violative product is not likely to cause adverse health likely to cause adverse health consequences. consequences.

CDRH Class III Recalls – CDRH Class III Recalls – Fiscal Year 2007 - 2012Fiscal Year 2007 - 2012

98108

74 7090

132

163

92

119

141

020406080

100120140160180

2007 2008 2010 2011 2012

Events Products

Root-Cause CategoriesRoot-Cause CategoriesFY 2010 – FY 2012FY 2010 – FY 2012

6%

49%

15%

19%

11%

Design Change ControlProcess Control Material/ComponentPackaging/Labeling

QUESTIONS??QUESTIONS??