PDF FDA Warning Letter to Envita Natural Medical Centers of ...

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DEPARTMENT OF HEALTH 3t HUMAN SERVICES

Food and Drug Administration

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Center for Biologics Evaluation and Research

1401 Rockville Pike Rockville MD 20852-1448

By Certified Mail - Return Receipt Requested And by Facsimile Transmission

CBER - 06 -- 006

JUN 1 4 2006

Warning Letter

Mr. Dino Prato Office Administrator Envita Natural Medical Centers of America 8759 East Bell Road Scottsdale, Arizona 85260

Dear Mr. Prato:

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natural killer cells that

The manufacturin 00 rocess involves th -and

of

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.

days to The

diagnostic

or

bears the therapeutic

Based on this Public Health (FD&C Act) .

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the

Page 2 - Envita Natural Medical Centers of America

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section 502(f)(1) bear adequate

This letter is not responsibility to regulations, and

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.

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Page 3 - Envita Natural Medical Centers of America

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eiirTnnfnehoifjnitteudisecnaetcdtWritiaoviayneotronntocufihoareninerngdnteeiflcLiimotengeirtiivttcboieelefaretmaticeitohstonneitirooFsefnascDcscuetlAeiaiidvonniniedtnc(/oasisolnp)yrveiowectnsiuthvttieeibhosgnoetcauico.ttgamiaPofmutlnuiosaerrseltashdsodieiefrsroqutnbnughoeaseotlfia.iscfdfeeivurcri.iatsotTheiuehodsrenntvsphaieraottoluaacrfcteeatieiiooldonufisnrntsegmhtsceao,oyouiwblmrshdepeislircunevlhcamtltemiuinnadoteyntshe Please send your written response to :

Christine J . Drabick OCFDfeiofvnoiitdcseeiraoonnffdoorCfDoBrIminuopsgllpoieAgacditnmciisconeEnisvsaatnalrdnuaatdBtiiioSoonulnrovgaeinicldslQaRuneacsleeita(yrHcFhM-664) 1401 Rockville Pike, Suite 200N Rockville, Maryland, 20852-1448 Telephone: (301) 827-6323

We request that below.

you

send

a

copy of your response

to

the

FDA

District

Office

listed

Sinc rely,

Mary A." Malarkey

Director

OCfefnitceerofforCoBmioplloigaincsceEvaanlduaBtiioolnogaincds

Quality Research

cc: Alonza E . Cruse, Director Los Angeles District Office Food and Drug Administration 19701 Fairchild, Suite 300 Irvine, California 92612-2506

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