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Friday, August 3, 2012 9:23 PM | MARIO MORAIS Volg link

SO I WAS TRYING TO GET A HOLD AF MS. ANN WION AT 301-796-8722. JUST TO ASK HER TO HELP ME AS CDRH IS AVOIDING ME. BUT MS WION SEEMS TO BE AVOIDING ME AS WELL. HOW CAN THESE PEOPLE SLEEP AT NIGHT!!


HERE IS MY LETTER TO MS. WION AND I SENT A COPY TO MS HAMBURG BUT ALAS ---NOTHING--


PLEASE CALL YOUR GOVERNMENT!!!!!!!!!!!!!!


-------------------------------------------------------------------------1-OF-10


MARIO MORAIS


4 GLEN ROAD, APARTMENT # 103


HUDSON, MASS., 01749-1365


PHONE: 978-212-5156 / Email: marioTTTmorais8@gmail.com


-------------------------------------------LETTER-DATE AUGUST 03, 2012


Organization of the Office of Chief Counsel, Food and Drug Administration


MS. ANN WION / DEPUTY CHIEF COUNCIL


10903 NEW HAMPSHIRE AVENUE


SILVER SPRINGS, MD 20993


ALSO


Ms MARGARET HAMBURG / COMMISSIONER OF FDA


WASHINGTON, DISTRICT OF COLUMBIA


OFF # 301-796-5000 / FAX 301-796-9840 / Margaret.Hamburg@fda.hhs.gov


OFF # 301-796-8722 / FAX 301-847-8618 / Ann.Wion@fda.hhs.gov


DEAR MS. ANN WION AND MS. MARGARET HAMBURG;


MS.ANN WION IS DEPUTY CHIEF COUNSEL 'Good morning. I am Ann Wion, deputy chief counsel for program review in the Office of the Chief Counsel'. SO HOW CAN A PERSON THAT HIGH IN THE OFFICE OF CHIEF COUNSEL AVOID ME!


MS. ANN WION PLEASE TELL ME WHY YOU ARE AVOIDING ME NOW!


I HAVE CALLED YOU MANY TIMES AND EACH TIME I CALL I GET YOUR ANSWERING MACHINE IT SAYS 'sorry ANN WION is not available, record your message at the tone, when you are finished, hang up or hold for more options. I ALWAYS LEAVE A MESSAGE TO CALL ME BACK BUT YOU DO NOT CALL ME BACK!


I SENT YOU THE EMAIL ON JULY 11 2012 AND JULY 22, 2012, SHOWING THAT I AM BEING IGNORED BY THE CDRH GROUP. THE PROF THAT I SENT YOU THE EMAILS IS BELOW FOR YOUR REVIEW! MAYBE YOU MISSED THE LETTER BUT YOU HAVE TO CALL ME BACK FOR ME TO KNOW!


ISN'T YOUR ORGANIZATION RESPONSIBLE FOR HELPING TO REGULATE LEGALITY AT THE FDA! I GUESS THE ANSWER IS NO!


WHY ARE MOST OF THE MEMBERS OF YOUR OFFICE 'general lawyers'. YET THAT SAME AGENCY DOES NOT ASSURE THAT THE FDA FOLLOWS THE LAW!


--------------------------------------------------------------------------2-OF-10


MY ONLY CRIME IS CCSVI BENEFITED MY MULTIPLE SCLEROSIS, AND MY REWARD IS AVOIDANCE BY THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH --CDRH--! I BELIEVE CDRH IS THE REASON AMERICANS DON’T HAVE A BENEFICIAL PROCEDURE FOR MULTIPLE SCLEROSIS


THE FDA NEWS ANNOUNCEMENT ABOUT CCSVI, said the FDA wants to protect the public but the FDA'S actions are avoiding the public. the FDA's actions are NOT PROTECTING THE PUBLIC, The FDA will not admit they even received my letter thus will not answer my letter. IN MY OPINION THE CDRH GROUP IS VERY CORRUPT!


THE FDA HAS NO OVER SITE OR ACCOUNTABILITY, AND THE CHECKS AND BALANCES AT THE FDA ARE NOT WORKING.


MS. LINDSAY LLOYD LIES TO ME AND WILL NOT ACCEPT MESSAGES FROM ME, ALSO DR. WILLIAM MAISEL WILL NOT ANSWER MY EMAILS, ALSO MR. JEFF SHUREN WILL NOT ANSWER MY EMAILS. THE CDRH OMBUDSMAN WILL NOT ANSWER EMAILS, MR. DAVID BUCKLES THE CDRH OMBUDSMAN WILL NOT TAKES MY MESSAGES, AND MR. BUCKLES WILL NOT ANSWER HIS EMAILS, ALSO THE DEPUTY CDRH OMBUDSMAN WILL NOT TAKE MY MESSAGES OR ANSWER HIS EMAILS!


WHAT KIND OF OVER SITE OR ACCOUNTABILITY DOES THE FDA HAVE! NO LEGAL OVER SITE BY THE OFFICE OF THE CHIEF COUNSEL!


I HOPE THE FOLLOWING PARAGRAPH EXPLAINS WHAT IS HAPPENING!


----------------------------FRIDAY JULY 20, 2012-----------------------------------


AGAIN, I RECALLED MS. LLOYD AT 1-301-796-4866 ON FRI JULY 20, 2012 AT 11;05 AGAIN TODAY MS. LLOYD’S MESSAGE SAYS 'the party you are trying to reach is not accepting calls at this time' ALSO I CALLED THE DEVICE MAIN NUMBER AT 1-301-796-5900 THE MESSAGE SAID 'the party you are trying to reach is not accepting calls at this time' I DO NOT BELIEVE THAT THE MAIN TELEPHONE NUMBER COULD LEGALLY DO THIS ! I ALSO CALLED MR BUCKLES AT 301-796-5447, AGAIN TODAY MR BUCKLE'S PHONE MESSAGE SAYS 'the party you are trying to reach is not accepting calls at this time'. FINALLY I CALLED MR. ROMANELL AT 301-796-5436 AND AGAIN MR BROMANELL'S PHONE MESSAGE SAYS 'the party you are trying to reach is not accepting calls at this time'.


--------------NO ONE HAS ALLOWED ME TO LEAVE A MESSAGE OR NO ONE HAS ANSWERED MY EMAIL----------------------------------------------------------



IF YOU HAVE ANY QUESTIONS FEEL FREE TO CALL ME AT 978-212-5156 OR EMAIL ME AT: marioTTTmorais8@gmail.com


-----------------------------------------------------------------------3-OF-10


SINCERELY YOURS,


MARIO MORAIS,


EMAILED TO THE FOLLOWING FOLKS; Margaret.Hamburg@fda.hhs.gov, Ann.Wion@fda.hhs.gov, ALSO FAXED TO THE OFFICE OF THE COMMISSIONER AT 301-796-9840, AND MS WION AT 301-847-8618


--------------------------------------------------------------------------------


ALSO ON AUGUST 03, 2012 EMAILED TO FOLLOWING FOLKS


Margaret.Hamburg@fda.hhs.gov, Ann.Wion@fda.hhs.gov, Afia.Asamoah@fda.hhs.gov, Kathy.applewhite@hhs.gov, cynthia.douglas@hhs.gov, gloria.ellis@hhs.gov, john.gallivan@hhs.gov, karen.giles@hhs.gov, elaine.gross@hhs.gov, elaine.gross@hhs.gov, mathew.grove@hhs.gov, ottis.hamilton@hhs.gov, suzanne.hassett@hhs.gov, jamar.hawkins@hhs.gov, cynthia.kenny@hhs.gov, Christopher.Cavanaugh@hhs.gov, thomas.kuchenberg@hhs.gov, annie.lamb@hhs.gov, ekatrini.malliou@hhs.gov, oliver.potts@hhs.gov, denise.rich@hhs.gov, michael.smith@hhs.gov, vivian.stallion@hhs.gov, darlene.taylor@hhs.gov, agnes.thomas@hhs.gov, talaiya.upchurch@hhs.gov, linda.wills@hhs.gov,


------------------------------------------------------------------------------------


------------------------------------------------------------------------------------


-----------------------SUPPORTING DOCUMENTATION--------------------------


==========================================================


------------------------------------------------------------------------------------


---------------------------------------------------------------------------


HERE ARE THE PAST EMAILS I HAVE SENT TO MS. ANN WION


------------------------------------------------------------------------------------


from:---------------anncartermjackbrown@gmail.com


to:-------------------ann.wion@fda.hhs.gov,


----------------------Afia.Asamoah@fda.hhs.gov


date:---------------Wed, Jul 11, 2012 at 1:40 PM


subject:------------MS. ANN WION IS THE CDRH OFFICE ALLOWED TO LIE TO ME THEN AVOID ME...


mailed-by:---------gmail.com


------------------------------------------------------------------------------------


MS. WION



I HAVE ALWAYS TALKED WITH THE UTMOST RESPECT BUT MS. LINDSAY LLOYD ,AT 1-301-796-4866, LIED AND AVIODS ME, THE MAIN NUMBER 1-301-796-5900 AVOIDS ME, THE CDRH OMBUDSMAN, MR. DAVID BUCKLES, AT 1-301-796-5447 AVOIDS ME AN EVEN THE DEPUTY OMBUDSMAN, MR. ROMANELL AT 301-796-5436 AVOIDS ME.


-------------------------------------------------------------------------------4-OF-10


SHOULD I BE LIED TO THEN AVOIDED! PLEASE ANSWER!!!!!!!!!!!!!



----------------------------WEDNESDAY JULY 11, 2012-----------------------------------


I RECALLED MS. LLOYD AT 1-301-796-4866 ON WED JULY 11, 2012 AT 11;24 STARTING TODAY MS. LLOYD MESSAGE SAYS 'the person you are trying to reach is not accepting calls at this time' ALSO I CALLED THE DEVICE MAIN NUMBER AT 1-301-796-5900 LEFT MESSAGE! I ALSO CALLED MR BUCKLES AT 301-796-5447, AGAIN TODAY MR BUCKLE'S PHONE MESSAGE SAYS 'the person you are trying to reach is not accepting calls at this time'. FINALLY I CALLED MR. ROMANELL AT 301-796-5436 AND LEFT A MESSAGE!


--------------NO ONE HAS RETURNED MY CALL OR MY EMAIL----------------



MARIO MORAIS


-------------------------------------------------------------------------------===========================================================


-------------------------------------------------------------------------------


NEXT EMAIL TO MS. ANN WION


------------------------------------------------------------------------------


from:----------------anncartermjackbrown@gmail.com


to:--------------------ann.wion@fda.hhs.gov,


-----------------------Afia.Asamoah@fda.hhs.gov


date:----------------Mon, Jul 16, 2012 at 5:21 PM


subject:-------------PLEASE CALL ME....AT 978-212-5156---THANK YOU IN ADVANCE


mailed-by:---------gmail.com


-------------------------------------------------------------------------------------


DEAR MS. ANN WION;



I HAVE CALLED TWICE AND ASKED VERY NICELY TO PLEASE CALL ME BACK!



MS. LLOYD AT 1-301-796-4866 IS STILL AVOIDING ME, ALSO THE DEVICE MAIN NUMBER AT 1-301-796-5900 IS STILL AVOIDING ME, ALSO MR BUCKLES AT 301-796-5447, THE CDRH OMBUDSMAN IS STILL AVOIDING ME, ALSO MR. ROMANELL AT 301-796-5436 THE CDRH DEPUTY OMBUDSMAN IS STILL AVOIDING ME!



HERE IS A COPY OF AN EMAIL I SENT YOU;


----------------------------------------------------------------------------------


from:---------------anncartermjackbrown@gmail.com


to:-------------------ann.wion@fda.hhs.gov,


----------------------Afia.Asamoah@fda.hhs.gov


date:---------------Wed, Jul 11, 2012 at 1:40 PM


subject:------------MS. ANN WION IS THE CDRH OFFICE ALLOWED TO LIE TO


-----------------------------------------------------------------------5-OF-10


ME THEN AVOID ME...


mailed-by:---------gmail.com


--------------------------------------------------------------------------------


MS. WION


I HAVE ALWAYS TALKED WITH THE UTMOST RESPECT BUT MS. LINDSAY LLOYD ,AT 1-301-796-4866, LIED AND AVIODS ME, THE MAIN NUMBER 1-301-796-5900 AVOIDS ME, THE CDRH OMBUDSMAN, MR. DAVID BUCKLES, AT 1-301-796-5447 AVOIDS ME AN EVEN THE DEPUTY OMBUDSMAN, MR. ROMANELL AT 301-796-5436 AVOIDS ME.


SHOULD I BE LIED TO THEN AVOIDED! PLEASE ANSWER!!!!!!!!!!!!!


----------------------------WEDNESDAY JULY 11, 2012-----------------------------------


I RECALLED MS. LLOYD AT 1-301-796-4866 ON WED JULY 11, 2012 AT 11;24 STARTING TODAY MS. LLOYD MESSAGE SAYS 'the person you are trying to reach is not accepting calls at this time' ALSO I CALLED THE DEVICE MAIN NUMBER AT 1-301-796-5900 LEFT MESSAGE! I ALSO CALLED MR BUCKLES AT 301-796-5447, AGAIN TODAY MR BUCKLE'S PHONE MESSAGE SAYS 'the person you are trying to reach is not accepting calls at this time'. FINALLY I CALLED MR. ROMANELL AT 301-796-5436 AND LEFT A MESSAGE!


--------------NO ONE HAS RETURNED MY CALL OR MY EMAIL----------------


--------------------------------------------------------------------------------


HERE ARE THE DAYS I SENT YOU A COPY OF EMAILS THAT PROVE THE CENTER FOR DEVICE AND RADILOGIC HEALTH --CDRH-- IS AVOIDING ME!


------------------------------------------------------------------------------------


EMAILED ON JULY 11, TO FOLLOWING FOLKS; lindsay.lloyd@fda.hhs.gov,


william.maisel@fda.hhs.gov, CDRHOmbudsman@fda.hhs.gov, david.buckles@fda.hhs.gov, lawrence.romanell@fda.hhs.gov,


christine.merenda@fda.hhs.gov, deborah.miller@fda.hhs.gov, synim.rivers@fda.hhs.gov, brenda.rose@fda.hhs.gov, theresa.toigo@fda.hhs.gov, james.valentine@fda.hhs.gov, jay.wattenberg@fda.hhs.gov, linda.wolfrey@fda.hhs.gov, OSHI@fda.hhs.gov,


Afia.Asamoah@fda.hhs.gov, heidi.marchand@fda.hhs.gov,


raph.tyler@fda.hhs.gov, ann.wion@fda.hhs.gov,


dominic.cirincione@fda.hhs.gov, lisa.dwyer@fda.hhs.gov, FDATRACK@fda.hhs.gov, FDACriticalpathprogram@fda.hhs.gov, TRANSPARENCY.MEETING@fda.hhs.gov,


-----------------------------------------------------------------------------------


EMAILED ON JULY 22, TO FOLLOWING FOLKS; lindsay.lloyd@fda.hhs.gov,


william.maisel@fda.hhs.gov, CDRHOmbudsman@fda.hhs.gov,


-------------------------------------------------------------------------6-OF-10


david.buckles@fda.hhs.gov, lawrence.romanell@fda.hhs.gov, jeff.shuren@fda.hhs.gov, dsmica@fda.hhs.gov, fda@service.govdelivery.com, support@govdelivery.com, webmail@oc.fda.gov, raph.tyler@fda.hhs.gov, ann.wion@fda.hhs.gov, soumya.patel@fda.hhs.gov, mayo.shirley@fda.hhs.gov, jennifer.tomasello@fda.hhs.gov, martina.varnado@fda.hhs.gov, Afia.Asamoah@fda.hhs.gov, jordana.ogrady@fda.hhs.gov, ginger.prather@fda.hhs.gov, kathleen.burns@fda.hhs.gov, lisa.barclay@fda.hhs.gov, crystal.smith@fda.hhs.gov,


brian.botsford@fda.hhs.gov, mame.diallo@fda.hhs.gov, michelle.difilippo@fda.hhs.gov, julie.frandsen@fda.hhs.gov, dynna.bigby@fda.hhs.gov, claudia.grillo@fda.hhs.gov, valerie.jackson@fda.hhs.gov, shawnee.jacobs@fda.hhs.gov, yolanda.jenkins@fda.hhs.gov, marilyn.khan@fda.hhs.gov, leslie.herbert@fda.hhs.gov,


---------------------------------------------------------------------------------


EMAILED ON AUGUST 03, TO FOLLOWING FOLKS; lindsay.lloyd@fda.hhs.gov,


william.maisel@fda.hhs.gov, CDRHOmbudsman@fda.hhs.gov, david.buckles@fda.hhs.gov, lawrence.romanell@fda.hhs.gov, jeff.shuren@fda.hhs.gov, dsmica@fda.hhs.gov,


sam_jonsson@scottbrown.senate.gov, jack_richard@scottbrown.senate.gov,


diane.sullivan@fda.hhs.gov, athena.tang@fda.hhs.gov, darian.tarver@fda.hhs.gov, shanita.washington@fda.hhs.gov, daniel.wilmoth@fda.hhs.gov, ann.witt@fda.hhs.gov, tiffany.yu@fda.hhs.gov, stacy.zellers@fda.hhs.gov,


ann.wion@fda.hhs.gov,


pam.pisner@fda.hhs.gov, shelisha.saunders@fda.hhs.gov, daniello.sepe@fda.hhs.gov, shelisha.saunders@fda.hhs.gov, pam.pisner@fda.hhs.gov, shelisha.saunders@fda.hhs.gov, daniello.sepe@fda.hhs.gov, kerry.bingham@fda.hhs.gov, linda.bren@fda.hhs.gov, Afia.Asamoah@fda.hhs.gov,


beth.martino@fda.hhs.gov, jason.brodsky@fda.hhs.gov, joshua.budich@fda.hhs.gov, mildred.cooper@fda.hhs.gov, michael.ermarth@fda.hhs.gov, lesley.maloney@fda.hhs.gov, kenneth.nolan@fda.hhs.gov, ellen.rogers@fda.hhs.gov, kay.springer@fda.hhs.gov, deborah.tedford@fda.hhs.gov,









------------------------------------------------------------------------7-OF-10


-----------------------------------------------------------------------------------


HERE ARE THE PAST EMAILS I HAVE SENT TO MS. ANN WION


-----------------------------------------------------------------------------------


from:---------------anncartermjackbrown@gmail.com


to:-------------------ann.wion@fda.hhs.gov,


----------------------Afia.Asamoah@fda.hhs.gov


date:---------------Wed, Jul 11, 2012 at 1:40 PM


subject:------------MS. ANN WION IS THE CDRH OFFICE ALLOWED TO LIE TO ME THEN AVOID ME...


mailed-by:---------gmail.com


-------------------------------------------------------------------------


MS. WION



I HAVE ALWAYS TALKED WITH THE UTMOST RESPECT BUT MS. LINDSAY LLOYD ,AT 1-301-796-4866, LIED AND AVIODS ME, THE MAIN NUMBER 1-301-796-5900 AVOIDS ME, THE CDRH OMBUDSMAN, MR. DAVID BUCKLES, AT 1-301-796-5447 AVOIDS ME AN EVEN THE DEPUTY OMBUDSMAN, MR. ROMANELL AT 301-796-5436 AVOIDS ME.



SHOULD I BE LIED TO THEN AVOIDED! PLEASE ANSWER!!!!!!!!!!!!!



----------------------------WEDNESDAY JULY 11, 2012-----------------------------------


I RECALLED MS. LLOYD AT 1-301-796-4866 ON WED JULY 11, 2012 AT 11;24 STARTING TODAY MS. LLOYD MESSAGE SAYS 'the person you are trying to reach is not accepting calls at this time' ALSO I CALLED THE DEVICE MAIN NUMBER AT 1-301-796-5900 LEFT MESSAGE! I ALSO CALLED MR BUCKLES AT 301-796-5447, AGAIN TODAY MR BUCKLE'S PHONE MESSAGE SAYS 'the person you are trying to reach is not accepting calls at this time'. FINALLY I CALLED MR. ROMANELL AT 301-796-5436 AND LEFT A MESSAGE!


--------------NO ONE HAS RETURNED MY CALL OR MY EMAIL----------------



MARIO MORAIS


---------------------------------------------------------------------------------


=====================================================


-----------------------------------------------------------------------------------


NEXT EMAIL TO MS. ANN WION


------------------------------------------------------------------------------


from:----------------anncartermjackbrown@gmail.com


to:--------------------ann.wion@fda.hhs.gov,


-----------------------Afia.Asamoah@fda.hhs.gov


date:----------------Mon, Jul 16, 2012 at 5:21 PM


subject:-------------PLEASE CALL ME....AT 978-212-5156---THANK YOU IN ADVANCE


------------------------------------------------------------------------8-OF-10


mailed-by:---------gmail.com


----------------------------------------------------------------------------


DEAR MS. ANN WION;



I HAVE CALLED TWICE AND ASKED VERY NICELY TO PLEASE CALL ME BACK!



MS. LLOYD AT 1-301-796-4866 IS STILL AVOIDING ME, ALSO THE DEVICE MAIN NUMBER AT 1-301-796-5900 IS STILL AVOIDING ME, ALSO MR BUCKLES AT 301-796-5447, THE CDRH OMBUDSMAN IS STILL AVOIDING ME, ALSO MR. ROMANELL AT 301-796-5436 THE CDRH DEPUTY OMBUDSMAN IS STILL AVOIDING ME!



HERE IS A COPY OF AN EMAIL I SENT YOU;


----------------------------------------------------------------------------------


from:---------------anncartermjackbrown@gmail.com


to:-------------------ann.wion@fda.hhs.gov,


----------------------Afia.Asamoah@fda.hhs.gov


date:---------------Wed, Jul 11, 2012 at 1:40 PM


subject:------------MS. ANN WION IS THE CDRH OFFICE ALLOWED TO LIE TO ME THEN AVOID ME...


mailed-by:---------gmail.com


--------------------------------------------------------


MS. WION


I HAVE ALWAYS TALKED WITH THE UTMOST RESPECT BUT MS. LINDSAY LLOYD ,AT 1-301-796-4866, LIED AND AVIODS ME, THE MAIN NUMBER 1-301-796-5900 AVOIDS ME, THE CDRH OMBUDSMAN, MR. DAVID BUCKLES, AT 1-301-796-5447 AVOIDS ME AN EVEN THE DEPUTY OMBUDSMAN, MR. ROMANELL AT 301-796-5436 AVOIDS ME.


SHOULD I BE LIED TO THEN AVOIDED! PLEASE ANSWER!!!!!!!!!!!!!


----------------------------WEDNESDAY JULY 11, 2012-----------------------------------


I RECALLED MS. LLOYD AT 1-301-796-4866 ON WED JULY 11, 2012 AT 11;24 STARTING TODAY MS. LLOYD MESSAGE SAYS 'the person you are trying to reach is not accepting calls at this time' ALSO I CALLED THE DEVICE MAIN NUMBER AT 1-301-796-5900 LEFT MESSAGE! I ALSO CALLED MR BUCKLES AT 301-796-5447, AGAIN TODAY MR BUCKLE'S PHONE MESSAGE SAYS 'the person you are trying to reach is not accepting calls at this time'. FINALLY I CALLED MR. ROMANELL AT 301-796-5436 AND LEFT A MESSAGE!


--------------NO ONE HAS RETURNED MY CALL OR MY EMAIL----------------


MARIO MORAIS