Presentation #5 - Effective Investigations

7/29/2019 Presentation #5 - Effective Investigations

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Presentation #5

Enforcement Activities

FDA-483, WL, Recalls

Recent Events


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Establishment Inspections vs. FDA-483 Issued (SJN-DO)

FYEI

Conducted483 Issued %

2008 18 11 61%

2009 11 6 55%

2010 14 10 71%


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Top 3 Observations (SJN-DO)

Medical Devices

CITATION FY 2008 FY 2009 FY 2010 TOTAL

820.100 (b)

CAPA 3 2 6 11

820.75 (a)

Process

Validations

4 2 4 10

820.198 (a)

Complaint Files4 2 3 9


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Top 10 Medical Device Observations

for FY 2010 Nationwide

Reference Short Description Count

21CFR820.198(a) Complaint Handling Procedures not established 1083

21CFR820.100(a) CAPA Procedures Incomplete/Not Implemented/Notfollowed

1050

21CFR803.17 MDR Procedures have not beendeveloped/maintained/implemented

929

21CFR820.100b CAPA activities and/or results have not been[adequately] documented

836

21CFR820.75 Process whose results cannot be fully verified has notbeen [adequately] validated

779

21CFR820.22 Quality Audits/Re-Audits have not been performed 725

21CFR820.22 Procedures for Quality Audits have not been[adequately] established

633

21CFR820.20 Effective Quality System Not Implemented 615

21 CFR820.30(a) Design Control Procedures not established 603

21CFR820.30 (i) Design Change Procedures not established 536


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Top 5 Observations for

FY 2010 SJN-DO Medical Devices

Observation Description Count

820.100 (b)Lack of documentation

of CAPA activities6

820.70 (a)

Process Controls

Procedures 4

820.75 (a)

Lack of process

validation activities

and/or documentation

4

820.100 (a)

CAPA procedures not

[adequately]

established

4

820.198 (a)Complaint files not

adequately maintained3


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Observation Description

820.90 (a) Control of nonconforming product

820.80(d)Receiving, in-process, and finished

device acceptance.

820.100(a)(3) & (a)(5) CAPA

820.198(c) Complaint files

820.6 Distribution

820.22 Quality Audits

Top deficiencies cited in SJN-DO

Warning Letters from 2007-2010


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Recalls 2009

Medical Devices Drugs

Jan 3 3

Feb 3 3

Mar 1 2

Apr 2 3

May 2 2

Jun 3 0

Jul 6 3

Aug 2 1

Sep 4 1Oct 5 1

Nov 3 2

Dec 3 4

Total 37 25

At least one of them report sterility/particulate issues


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Corrective and Preventive Action One of the three(3) top observation for 483s issued in 2010

by the FDA.

Cited in 6 out of 11 inspections conducted in FY 2010

Main Observations

CAPA Procedures incomplete/not implemented/ not followed

CAPA activities and/or results have not been (adequately)

documented

Lack of documentation of CAPA activity

CAPA procedures not (adequately) established


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Recent Developments How they might impact future FDA Inspections

Tolerance of Regulatory Agencies

Warning Letters

Corrections without delay

Inspections directed towards previous corrections

Thorough review of Quality Systems

Recalls and their extension should be few and farapart.

Supplier purchase agreements, quality agreementsqualification and audits might be closely scrutinized.


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Corrective and Preventive ActionTools used to identify real root cause are:

Cause-Effect/Fishbone diagram

5Whys

DMAIC

Is/Is Not Diagram

Trend analysis- history records

Contradiction MatrixFlow Charts

Time line

Mistake Proofing


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FMEA A failure modes and effects analysis (FMEA)

is a procedure for analysis of potential failure modeswithin a system for classification by the severity and

likelihood of the failures

helps identify potential failure modes based on pastexperience with similar products or processes

widely used in manufacturing industries in various

phases of the product life cycle

is designed to improve the quality and reliability ofdesigns

is a living document


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FMEAFailure modes

Any errors or defects in a process, design, or

item, especially those that affect thecustomer, and can be potential or actual.

Effects analysis

Refers to studying the consequences of those

failures.


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FMEA Step 1: Severity

Step 2: Occurrence (or probability)

Step 3: Detection (failure to detect)

Usual range used is 1 to 10

Risk priority numbers (RPN ) = (Severity) x(Occurrence) x (Detection)


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Discussion of recent FDA-483 andWarning Letter citations and Recalls


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Concerns

Clarifications

Question and Answer

Session

Presentation #5 - Effective Investigations

Documents

Transcript of Presentation #5 - Effective Investigations