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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
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