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FDA Fines American Red Cross

FDA Fines American Red Cross

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Published by LansingStateJournal
This letter describes the results of FDA inspections into American Red Cross blood centers and the resulting fines of more than $9.6 million for violations. For the full story on blood safety and the business of blood, visit www.lsj.com.
This letter describes the results of FDA inspections into American Red Cross blood centers and the resulting fines of more than $9.6 million for violations. For the full story on blood safety and the business of blood, visit www.lsj.com.

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Published by: LansingStateJournal on Sep 27, 2013
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01/09/2014

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("~·
DEPARTMENT
OF
HEALTH
AND HUMAN SERVICES
Food and Drug Administration
'~~'-
Baltimore District OfficeCentralRegion6000MetroDrive, Suite
101
Baltimore,
MD
21215Telephone: (410) 779-5455FAX: (410) 779-5707
January
13
,2012ADVERSE DETERMINATION LETTER
BY
FACSIMILEAND CERTIFIED MAILRETURN RECEIPT REQUESTED
Mr.
J. Chris HroudaExecutiveVice PresidentBiomedicalServicesAmerican National RedCross2025EStreet, N.
W.
Washington,D.C. 20006 RE:
United States
v.
American National
Red
Cross,
Civil Action No. 93-0949(JGP)Dear
Mr
.Hrouda:FromApril through October 2010, United States Food and Drug Administration(FDA)investigators inspectedsixteenAmerican National Red Cross (ARC) Blood Services facilities and observedsignificant violations
of
thelaw,regulations,and the Amended ConsentDecree
of
Permanent Injunction,entered on
April15
,2003(Decree).
At
theconclusion
of
each inspection,the investigators issuedFormsFDA483,InspectionalObservations(FDA483), attached hereto (Attachment A).FDAis now, pursuant to paragraph VIII
of
the Decree, notifying ARC
of
its determination that ARC hasviolatedtheFederal Food,Drug, and Cosmetic
Act
,FDAregulations, and the Decree, specifically
21
U.S.C.
§
351(a)(2)(B),paragraphs IV.A.,
IV.B.l,
IV.B.IO, and XIX
of
the Decree and Title21, CFR
§
210-211and
§
600-680.The 2010 inspections cited herein were conducted at the following ARC facilities on thefollowingdates:BadgerHawkeyeRegion, 4860 Sheboygan Avenue,Madison, WI, 4/5-23/10 GreatLakesRegion,1800 East Grand River Avenue,Lansing,MI, 4/5-27110 Penn Jersey Region, 700 Spring Garden Street,Philadelphia, P A,5/24/10 -6/4110 ConnecticutRegion,209 Farmington Avenue,Farmington,CT,5/4110-6115/10 DetroitNationalTesting Laboratory, 100EliotStreet, Detroit,
MI
,
5/25/10-6/16/10
Indiana-Ohio Region, 1212EastCalifornia Road,Ft.Wayne, IN, 7/12-21/10 Southwest Region, 10151 East 11th Street,
Tu
lsa,OK,
7/26/10-
8/9110AppalachianRegion, 352 Church Avenue,SW, Roanoke, VA, 8/3-13/10 Heart
of
America Region,405 West John H. Gwynn
Jr
.Avenue, Peoria, IL, 6/21/10-8/18/10
 
Page
2-
Mr.
J.
Chris HroudaNorthern California Region, FixedCollections/DistributionSite, 2731 North First Street,San Jose, CA,
917-13110
Arizona Region, Broadway Fixed Collection Site,7139EastBroadway Blvd.,Tucson,AZ, 9/7-15110 Northern Ohio Region, 3747 Euclid Avenue, Cleveland, OH, 8/27/10-9/23/10Southern California Region, 100 Red Cross Circle, Pomona, CA, 8/9/10 -9/24/10Greater Alleghenies Region,250Jari Drive, Johnstown, PA, 9/7-24/10Southeastern Michigan Region, 100 Mack Avenue, Detroit, MI, 8/24110-9/27/10Donor and Client Support Center, 700 Spring Garden Street, Philadelphia, PA,
9/2/10-
10/29110The Decree requires ARC
to
establish and properly implement appropriate quality assurance (QA) andquality control(QC)measures. Proper
QA
and
QC
programs
by
blood establishments include measuresto prevent, detect, investigate, evaluate,and correct errors. The goals
of
these programs includepreventing the distribution
of
unsuitable blood products,and preventing the causes
of
recurrentproblems. The proper implementation
of
a strong
QA
programisessential
to
ensure thesafety
of
thenation
's
blood supply.Decree paragraph IV requires ARC to"establish,implement, and continuously maintainadequate methods, facilities, systems, and controls to ensure that
ARC
does not collect,manufacture, process,pack, hold, or distribute any article
of
drugasdefined in
21
U.S.C.
§
321(g), including any article
of
blood, bloodcomponent,
or
other biological product as defined in 42 U.S.C.
§
262,that is adulterated,within the meaning
of21
U.S.C.
§
351(a)(2)(B); misbranded, within the meaning
of21
U.S.C.
§
352(a)or 42 U.S.C.§ 262(b);
or
otherwise in violation
of
the
FD&C Act,
the
PHS
Act,
and regulationspromulgated thereunder, including, but not limited to,
21
C.F.R. Parts 210-211 and Parts 600-680."ARC is also required to "take steps necessary
to
ensure continuous compliance with this Order,
the law,
and
ARC
SOPs
...
"
and "establish,document, and continuously maintain managerialcontrolover training and quality assurance
in
all
regions
and
laboratories."
Decree paragraph IV.A.1.
&
2.ARC isalso required toappointa director
of
quality assurance whoshall "prepareandsubmitquarterly quality assurance reports
in
writing to
ARC
seniormanagement
and
ARC
Biomedical Services seniormanagement
..
thatcompletelyand accurately:(i) describe the steps that have been andwillbetaken, with specific dates for implementation
of
eachstep,to establish, implement, and continuously maintainthe
QAIQC program;
and(ii)describe all unresolved
potentialsystem(systemic) problems,system (systemic)problems,
and
trends
and their correctiveactionstatus; and (iii) assess whether ARC is incompliance with
thelaw,
ARC
SOPs,
and this Order." Decree paragraph IV.A.2.
1
Violations observed and/or documented during the2010inspections include the items listed below.This isnot intended to be an all-inclusive list
of
violationsin ARC facilities.
DECREE
VIOLATIONS:
DecreeViolations:
Inadequate
Managerial Control
1.Failureto establish, implement and continuously maintain managerial control over
QA
in allregions and laboratories as required
by
paragraph
IV
.A.2.The development
of
written procedures andprocesses that areappropriatelymanaged and implemented are essential components
of
an effective QA
1
Decree paragraph
III
57 
defines
the
QNQC
program
as
the
"written
SOPs
forqualityassurance
and
quality control that
AR
C
mu
stestablish,implement,
and
continuouslymaintain under paragraph
IV
of
thisOrder
to
ensurethat
blood
and
blood components
are
collected,manufactured,processed,
packed
,
held
,and
di
stribu
tedby
ARC
in
accordance with
the
law,ARCSOPs,
and
this
Order,andhavethe
purity
that
they
purport
or
are
representedto
possess
."(Theitalics
in
the
quotations
from
the Decree are
in
the
original
and
indicatethat theitalicized
word
isdefinedin paragraphIll
of
the Decree.)
 
Page 3-
Mr
.
J.
ChrisHroudaprogram. ARC management, however,mergedcertainQA functions intocentralizedfacilities without ensuring that the new facilities were adequatelystaffedto perform these functions in a timely
or
effectivemanner.Beginning
May
2008,
ARC
began to consolidate certain donor management activities,
2
which werepreviously performed in 35
of
its 36 regional offices, into the Donor Client SupportCenter(DCSC). TheDCSC is located in two facilities, one inCharlotte,North Carolina, and one in Philadelphia, Pennsylvania.Theconsolidation began in May 2008 and was completed in March 2010. During theconsolidation, multiple internal audits and Problem Management (PM)/QA assessments were performedatthe two DCSC facilities.
3
The results
of
the internal audits and assessments and thesubsequentinternal investigations indicated that the DCSC was chronically understaffed and lacked the processcontrols toensuretimely and adequate performance
of
the donor management functions. In response tothe internal audits,the DCSC repeatedly promised corrective actions, some
of
which had not beencompleted
or
were ineffective at the time
of
theFDAinspectioninSeptember and October 2010. During the consolidation phase, ARC had periodic senior management meetings, Quality andComplianceOversight Committee (QCOC) meetings, and Board
of
Governors meetings in which theDCSC consolidation project was discussed.
4
Quarterly and annual QA and training reports were alsosubmittedto
ARC's
senior management.
5
The meeting minutes indicate that ARC management wasaware
of
the audit findings and the staffing and training deficiencies and that the QCOC was monitoringthe situation to determine whether the consolidationshouldcontinue as scheduled. Despite therepeated,significant internal audit findings, the consolidation was permitted to continue withonlyone delay. After the consolidation was completedinMarch 2010, the meeting minutes indicate that ARCmanagement continued
to
have concernsaboutthe DCSC performance.TheDCSC continued to
be
understaffedandhad a backlog
of
what ARCreportedas being approximately 18,000 donor management cases
6
that had
not
been process-verifiedasrequired in Work Instruction 11.3.028,
ProcessVerification,
Version 1.1, and Forml5.4.frm015,
Donor Reaction
and
Injury Record,
Version 1.2.Additionalinternal records that detail the
DCSC's
management control deficiencies includethefollowing:
2
Activitiesbeing performed
at
the
DCSC
include donorcare
and
qualification
fun
ctions,suchas answeringeligibility
qu
es
ti
ons
from
the
donors
;donor deferrals;post donation
andcall
backactivities,donor complicationsandcomplaints; receipt
of
t
es
t res
ults
and entry of heresults
into
the
NBCS
software;management
of
follow
up
testing
with
thedonor;donorreentry/reinstatement;deferral
and
surveillance management;managingdonorrequests for test results andblood types;donor notification
of
reactive
te
st r
es
ults and donor counseling;
and
military,state,and health department notifications.D
CS
C alsoperforms clientsupport servicesthat include
the
management
of
blood product retrievals;consignee notification
for
the release
of
unsuitable
blood
components;caseinvestigations
for
possibletransfusion transmittedinfections,adversereactions
and
bacterialcontaminations;lookbacks; andserving
as
the
liaison
for
regional/divisional medicaldirectors.
DCSC
'sdatamanagementfunctions include
th
e
managem
ent
of
the National DonorDeferral Registry andtheDonor File Checkprocess.Problemmanagementtasks
for
thePhiladelphia
DCSC
are
perfo
rmed
in
Philadelphia
aswell as
in
the
Charlotte
DC
SCand includesthe detection,inve
st
igation,evaluation,co
rre
ct
ion,
and monitoring
of
all problem
s,trends,
andsystem
problems.
3
Facility Audits:10/14-17/08 (Philadelphia),
10
/
14-16
/
08
(C
harlo
tte
),
3124
-27/09 (Charlotte),
612-5/09
{Philadelphia),
12115/09-1/6/10
(Philadelphia
),
10
/
6
22
/
09
(Charlotte),
4/20-22110
(Charlotte),5/
18-21110
(Charlotte);Problem Management Assessment
4/9/1
0;Quality
Assurance
As
sessment 4/
10
.
4
ManagementReviewMinutesforCollectionsand Donor
Man
agement:
2110/09
,
5/
15
/09,
8nt09,
1218
/
09
,3/19/
10
,
and
6/8/
10
;QCOCMeetings:
6127
/
08
,5/19/09,8/
27
/
09
,
9124
/
09
,
10
/9/
09
,
10122
/09,
11
/13/09,
12111
/
09
,2/25/
10
,
3124
/
10
,4/9/10,
4122110
,6/
11110
,6/24/10 and
8/13
/
10
;
Board
of
Governors'
Mee
tings:4/23/
08
,6/6/
08
,3/26/
09
,
5127/09
,6/18/
09
,
7122109
,
8127
/
09
,9/23/
09
,10/5/10,1
2/
14
/09,1
127/
10
,
2124/10
,
312
4/
10
,
4120/10
,6/9/
10
and 8/
25
/
10
5
Quarterly
QA
Reports:
ApriVJune
2008,2008
Annual QA
ReportOctober2007/September2008,October/December 2008,January/March2009, April/June 2009,2009
Annual
QAReportOctober 2008/September 2009,October/December 2009andJanuary/March
20
I 0;QuarterlyTrainingReports: April/June 2008,July/September2008,October/December 2008,January/March2009,April/June2009, July/September 2009,October/December 2009and January/March2010.
6
At
the
tim
e
of
FDA'sinspection
of
the
DCSC
,
FDA
determined that the backlog
of
donor management cases
requirin
gprocess
review
w
as
approximately
15
,000(
II
,
531
intheCharlotte facility and 3,552in
the
Philadelphia
facility)
andapproximately 5,200 unreviewed
DRIRs
(4,949
in
the
Charlotte facilityand306
in
thePhiladelphia facility).

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