FDA Adverse Determination Letter to the Red Cross

0.04 MB·English

by  FDA

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pal 2, 2004

RSE DEVERMINA TION LETTER

BY FAL
CERTIATED MAIL
REQUESTED

Mr, Alan MoCurry
Exouutive Viee Uresident and CHO
Biomedival Services

American National Reel Cross
2025 E Street, N.W,
‘Washingum, D.C 20008

RE: Cited States v. Amerivan National Red Cross, Civil Avtion No. 93-0949 (IGP)
Deak Mr, MeCuery

Paragraph 1¥.B.(7 a of the amended Consent Decree of Permanent Injunction (Deere) dated Apr 15,
2003, requares that within 30 days of eniry of the Devoe, the American National Red Cross (ARC) must
‘modily ts stondard operating peiscdure to ensure that its regional bload service acilvies (regions)
nobfy the Ford and Drug Adingatration (FDA) “in weiting within five Business dav ater a region has
failed to lneate any blood or blaxd eommporient within 72 hours ai the time that the region intially
‘eared that such blond or blow component as ol ss assigued location.” Box the period May 1S,
2003, through December 31. 2003, ARC repoited te EDA. that tailed to locare 47 units of bload oF
blood components thin 72 hours of initially learning that guch blood peoducts were not mm their
oxsigned lovaions. (Soe Attachment J.)

Ensuring raceabslay of blood and blood components is erties] to peoreciane public health. Any uow ot

blood or bload component, even ane iniially decmed suitable (or distahution, veal besame suhjewt 19

br exkhack raced. on subsequent information regarding donor suitability or infectious diseaxe
for 47

lest result for subsequent donations from the sayne donor. ARC's (alu ke mangatn craccabiliey
nics of bland oe bioud exo:ponents during the pind May (5, 2003, theough December 31. 2002
reflects failure to mentasn adequate mventory control.

Poragraph IVF. (Ps ot the Decree tales tht “PDA muy assis & penalty of up 10 51,000 for cach anit
‘of hlovd and each blood eareprnen thee ARC Tals lo iocute within 72 hous lee region ivy
learned that nich blood or bleed compancnt Was not i is assigned fovition,” dn this utstance, PDAs
assessing 2 penalty of SMD frearh of che 47 onic of blead or hexid cumponenss that ARC false ta
lowste within 72 Hors after vegan lered tat the Blood or Blaod gomponent was MB Fis

lucatton Those lost prachics are liste an tachment

ane
Mr. Alon MeCuny
age 2

‘Additionally, Paragraph 1V.B.17.a sates inal “within § business days thereafter, ARC shall notify FDA
in iriting of cach such last unit of bland or bloud component and if such timely notification is not mode,
EDA may assess penalty of up vo $10U0 fos each such catiication falure.” FDA ideantied twa
"ARC reports that were not submitted to KDA within five business days of the day that ARC initslly
learned that the blood ar blood componcals were notin thelr assigned locadons, ‘hove late reposts were
from one gion and were substantially late, spccitically, 14 and 82 days, (Soe Aachment 2.) In this
instance, FDA is assessing a penalty of SHO.UNU for the feper: that was 82 days late snd 5,000 for the
repos hat was 14 days late

“The total fine that KDA is imposing as $50,250. As provided in Paragraph IX of the Decree, if ARC
agrees with this adverse determination, muse within 20 digs of oveipt uf this fetter, noily FDA ai its
ageeernent and its intent 19 pay the fic. 1 ARC disagrees with FDA's adverse datermiantion, it must
respond in writing within 20 days of rozelp of this ecer, explaining ils reascars for divogyeaing with
FDA's determination. Your response must be submitted 10 me atthe Foal aed Doug Administration,
Baltimore District Office, 6000 Metra Drive, Suite ML, altimore, Maryland 21215, with a cepy 10
Jesse Gondmon, M.D., Director, Ceoter Ine Biclogics Pvaluation gd Research, 1401 Rockville Pike,
Site 200 %, Rockville, Maryland 20852]

Singetety yours.

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Dir, Palinore Disc

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ATTACHMENTS .

ve Marsha Jobason Evans
President & CEO
‘American National Red Coes
2025 8 Suet. N.W
Washington. BC. 20006

Mary Bleano
General Counsel

American National Rel Crass
2025 B Street, NW
Washington DO 70K

Dave T Met ugha
CChvinnan, Por! of Goveins
American Natianal Red Cis
2025 B Soret, 8.