0001193125-12-298745.txt : 20120710 0001193125-12-298745.hdr.sgml : 20120710 20120710170859 ACCESSION NUMBER: 0001193125-12-298745 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20120710 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120710 DATE AS OF CHANGE: 20120710 FILER: COMPANY DATA: COMPANY CONFORMED NAME: COOPER COMPANIES INC CENTRAL INDEX KEY: 0000711404 STANDARD INDUSTRIAL CLASSIFICATION: OPHTHALMIC GOODS [3851] IRS NUMBER: 942657368 STATE OF INCORPORATION: DE FISCAL YEAR END: 1031 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-08597 FILM NUMBER: 12956491 BUSINESS ADDRESS: STREET 1: 6140 STONERIDGE MALL RD STREET 2: STE 590 CITY: PLEASANTON STATE: CA ZIP: 94588 BUSINESS PHONE: 9254603600 MAIL ADDRESS: STREET 1: 6140 STONERIDGE MALL ROAD STREET 2: SUITE 590 CITY: PLEASANTON STATE: CA ZIP: 94588 FORMER COMPANY: FORMER CONFORMED NAME: COOPERVISION INC DATE OF NAME CHANGE: 19870701 8-K 1 d377159d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 10, 2012

 

 

THE COOPER COMPANIES, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   1-8597   94-2657368

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

6140 Stoneridge Mall Road, Suite 590, Pleasanton, California 94588

(Address of principal executive offices)

(925) 460-3600

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 8.01. Other Events.

CooperVision, Inc., a subsidiary of The Cooper Companies, Inc., received a letter from the United States Food and Drug Administration regarding the Warning Letter issued on December 5, 2011. The FDA reported that it has completed an evaluation of the Company’s corrective actions, and it appears the Company has addressed the violations contained in the letter.

A copy of the letter dated July 5, 2012, is attached and incorporated by reference.

Item 9.01. Financial Statements and Exhibits.

 

  (d) Exhibits:

 

Exhibit

No.

  

Description

99.1    Letter of the United States Food and Drug Administration dated July 5, 2012.


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

THE COOPER COMPANIES, INC.

By

 

/s/ Rodney E. Folden

 

Rodney E. Folden

Vice President and Corporate Controller

(Principal Accounting Officer)

Dated: July 10, 2012


INDEX TO EXHIBITS

 

Exhibit

No.

  

Description

99.1    Letter of the United States Food and Drug Administration dated July 5, 2012.
EX-99.1 2 d377159dex991.htm LETTER OF THE US FOOD AND DRUG ADMINISTRATION Letter of the US Food and Drug Administration

Exhibit 99.1

 

LOGO    
  DEPARTMENT OF HEALTH & HUMAN SERVICES
   

New York District

Food & Drug Administration

158-15 Liberty Avenue

Jamaica, NY 11433

July 5, 2012

Mr. John Weber

President

CooperVision, Inc.

6140 Stoneridge Mall Road

Pleasanton, CA 94588

Dear Mr. Weber:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2012-4 issued on December 5, 2011. Based on our evaluation of your written responses and follow-up inspection, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

 

Sincerely,

/s/ Frank Verni

LCDR Frank Verni, USPHS

Compliance Officer

FDA – New York District


CooperVision, Inc.

Page 2

 

O: addressee

 

cc: Mr. Fernando Torres

President of Americas

CooperVision, Inc.

6140 Stoneridge Mall Road

Pleasanton, CA 94588

 

cc: Mr. James Della Valle

Vice President of Distribution

CooperVision Inc.

180 Thruway Park Drive

West Henrietta, New York 14586-9798

 

cc: Ms. Bonnie Tsymbal

Director of Regulatory Affairs and Quality Assurance

CooperVision Inc.

180 Thruway Park Drive

West Henrietta, New York 14586-9798

GRAPHIC 3 g377159g09i34.jpg GRAPHIC begin 644 g377159g09i34.jpg M_]C_X``02D9)1@`!``$`>`!X``#__@`?3$5!1"!496-H;F]L;V=I97,@26YC M+B!6,2XP,0#_VP"$``("`@("`@("`@("`@("`@("`@("`@("`@("`@("`@(" M`@("`@,#`@(#`@("`P0#`P,#!`0$`@,$!`0$!`,$!`,!`@("`@("`@("`@," M`@(#`P,#`P,#`P,#`P,#`P,#`P,#`P,#`P,#`P,#`P,#`P,#`P,#`P,#`P,# M`P,#`P,#`__$`:(```$%`0$!`0$!```````````!`@,$!08'"`D*"P$``P$! M`0$!`0$!`0````````$"`P0%!@<("0H+$``"`0,#`@0#!04$!````7T!`@,` M!!$%$B$Q008346$'(G$4,H&1H0@C0K'!%5+1\"0S8G*""0H6%Q@9&B4F)R@I M*C0U-CH.$A8:' MB(F*DI.4E9:7F)F:HJ.DI::GJ*FJLK.TM;:WN+FZPL/$Q<;'R,G*TM/4U=;7 MV-G:X>+CY.7FY^CIZO'R\_3U]O?X^?H1``(!`@0$`P0'!00$``$"=P`!`@,1 M!`4A,08205$'87$3(C*!"!1"D:&QP0DC,U+P%6)RT0H6)#3A)?$7&!D:)BH*#A(6& MAXB)BI*3E)66EYB9FJ*CI*6FIZBIJK*SM+6VM[BYNL+#Q,7&Q\C)RM+3U-76 MU]C9VN+CY.7FY^CIZO+S]/7V]_CY^O_``!$(`#(`7P,!$0`"$0$#$0'_V@`, M`P$``A$#$0`_`/?/VH/VR_C1\)_C?X[\"^&+CP^OA_P^_AM-)CNM`2[NV_M3 MP=X>URYA><2,]Q,+W4[I@=B@(R+CY>0#YQ'_``4A^.B?>\0^!)>P"Z1IJXQW MYO*`&_\`#R#XZD\>)?`BC.0IT2P;:.PR+G''3(-`#)/^"BOQ]F\KR/$W@]'W M@XA\.Z-(MQ$K8DV&57=",%>KG(XQP``./_!0[]H$?>\1>&5]-WAW1QG'ULZ` M/1_AM_P4F^*&B:M#:_$K0M*\7Z,J$WB:)8V7A7Q!9QDA/M-H'NY+&\E#L@2W MN5LTHVDT#V.IZ-?"".5K M#4].F1'MY55L!XQ)`^QO*D=1F@#U9N$;@MA3\HQDX'09XR>E`'XY_$3]ICXT M>//VI+SX5_!GXAP^'_!EGJEKX=:ZETCPWJ%G;6_A.TEU/XD>,=0U'5--NY%L MX+>TU.UB>,1JALD?#_:0+<_0/T&>'_VJOBA\/?VH[;P3\2/B%#X@^%6HZH!8 M:N^E^%['39/!WCFPGU3X?^,$O].TBUEET^)-0T+[2SSJJ"VO@P;R@U&P;'[& M0.)(8Y%/#J'7D'`;Y@/E)'`.,`D<<$T`2T`?BMXTC6X_X*?^'[&:&">VG\4^ M'5G@N$62"98_@3IV$EB=661!+"K@,#RH.,C@`^:-?_;-^.VC>)_%&E6>K>#( M[/2-=U>RMT_X5QX()M[&VUO4],LUDA'&*`('_;!_:+>7S(O$^AQIP%^ MS>$/`"H@``;RE?29G'S`DCS&YSC'0`%B/]KW]I%P5'BZ'9_$UMX6\"P2#Z.N MA8Z>JF@#0MOVGH/&%I-X6_:(^'WACXAZ1)](\7GQG\,?$6 MBV?B;3M4T5FM=*^(GPNU2*2QO(;S3_-FAMO%^B"T-U)&&`M]07;&UO:7KVUN M;?(-OD?L3^T[\:K3X*/B!X>U2.:\U_1;;1?`VHVLQ7[1JGC.-+'1M:@ M,<;>ZLR8D@UBWTNT\-+)%N?[7>ZH[;%OEHV#8GUH^'_B7^SA MHVN?9K>?QU^S_J%CX&\81`?9KOQ%\&O&-['%X%GDN41Y!::#XANUT"-2LHMH M=3O'\P^:(XS;Y!M\C]J/V+_C.OQ@^#'AY[ZY:7Q7X(BMO!7BYI7+S7VHZ19) M%9:\>OEQZQI\45\5/20RKDXRQ^@?H?7E`'XN^+AC_@J-X:P/G'BW03[A#\"K M3!^F5;\J`/$_V4?BIX#^"_Q\^-'B'XCWEU9:)KT>L:':+9:-?ZK?_@H+^S'9K,6N_$CP6Z*5=/!&HE)L@A$ MBWE26+[%&Y$Y89`[`'?:Y^V%\$_"_CKPC\--2GUU?$_C(^`ET.*U\-71M"/B M.T2^&I;F]5UBM@SW-HTYQB#SR&R4;`!TWP@_:?\`AA\:O%7B[P7X*N=>DUWP M0VH#7%U30[O3+4#3-?N_#URUG=-,T*_C/H/[.?P&T:YU-QX3A MN_`FD?:)[B2.76?%OBR_;1];O;/S<26NA>![?1+42G?'+]HOP-\`_AO?7$/PN\`36GPV\-W*SR:C;V?ACP;;RZS\1_&`1$07][ MK%[9:L\=_B/[5//H\C;7D`)^@?H:VH^'M!_9S_:W\3_#OQC98^%/C*74_"6K MI>-(EOA_LB^*+C]FS]J M'Q'\*_%=_(FB^(;F[\$/>27#P6EYJ%O=O-\.O$P,A6*2VU;3]/O(XIL[3_PD M]LBL0!@V\@V\C]W8Y%D!*9*AL`]`<`9('H#D?530!^,7BXD?\%1_"C8QO\2: M`6[`8^!\*\>@Y/7TH`^=]?@_8B7Q+XHEN[/]IN34U\4^)&OXK36_`:VKZDNM M7C7HL'>R9GLA>27?EEB6$?E!B3EG`.=F3]AV:W\MM%_:A91Y+M%;ZY\,TN9% MBDCE>,R6EA'<2$HC9#.=V/G!H`ZSXNW>E:C^V!^SG?:'#J%KH=[;?LG7FDP: MJUL^IV^F27N@OIL&H/9DP&\6T:%93&<%PV,=``>X_P#!.)F/[0'[1;,-K$^. M05P1A1\6;\`X/(X)_*@#]=OB/XHTOP5X(\3^+-9DM(M*\.Z#K.LWLMZ56U2# M3-+N[YQ+(Q^198[=X``-S/<(H^]A@#^:KX-:7?:5\(?VG_$D\,EM80?#+P-\ M/6@E"H)O$7C?XH:&EM9JRJ52:NX2,*2T"C+1LRL`#:^#NF+X(^&_Q+_: M(N;K;JFGVC_\`!2;X06/BSX+CXD6-HS>(?AM<2/<216Z3 M3W/@O75@T_Q!;.`!(8=.ECL-:#%F$,>FZ@0%^U22(?H'Z'YD>,]2C^)_P3\& M_$.2#R/&7P:N=)^#WC>ZMR4N=<\$:O8S2?"7QE/+AA9?9=4T?4/"$SN)6%Z( MID:+<%4_0/T/W9_9@^+5O\9O@[X7\827EI/X@$(T7QA:V[8DL/%>BP066JQ7 M$9)/#T7T\SX*JV['MT MQ0!XG^S#\&_`WQJ_:+^)_A7Q]97U]HNF6OQ.\1VEO8:K?Z3,E_:>/?">GQDW M%C/&SH8+V<$,&'S<#/-`'Z/M_P`$ZOV8I8@O_"/^+$#A-X7QYXH52FY6>,*N MH`*C*"N!C`/'I0!^>G[1_AG2O!/[<'P5\,:,DD>B^'+[]FS1--@FFEGEBL=* M\2:=I>GK)]`'D_P`'_P!H#5/V>/BK\8/$VA:%I'B. MY\0^)?'F@26^KW4UG#9Q1_$/4M0^T1-:CS9)"8/+VEU4;@V"5P38-CH?C!^T MK\;OVJI-*^'FGZ'OMI]01[#P5X"M-0>36[]6VZ>-;O[V[GFNK*-F`D:]-C8Q MDB>X,2IE@#E/BG;-X$\(^%/V9_`^IV7C?7KGQ)IOC3XD7>@K]MCUWXO:I"?# M.C?#[13;82[L?#VGBWM-Z,9+J^NR9GBDC=P`6_B-X!U'4_'WP8_9/\*7\NHS M>"+;2/"&MW%B\&[]"[M( M4A-@V/LOQ;^VAF+X6T# M54N]0A2S:)=0FN=4N9)7BV^86#L,MDFWR#;Y'':C_P`%+?%>K65]I>H_"+P1 M?:9>6UQ9:C876H:G+:WUA=1M;7=C/%)"4N;:>SEFB<%-N'P5/2@#X[_9V\;> M%/#/Q"U/P[XKMX(/AG\4]`U'X:^,[61UN_[$T;7VA;P_KBA"OERZ!K.FZ-*0HK36^F6,B%D$QN$;%HVE^"@,9?:I,9;&WG!&1D`$&@#'_82B:']JSXLAH9(3+X:^*\ M<>^)XMS-\3O"$1'SJI^1[67=Z``]Z`/VI3A$]E7]`*`/P?\`VYM1;PO^V/I7 MBV.&WN)_#>B_##Q7:VU\'-I/=>'-0U74+6*3:RD6SW5C`CE70Y888$!@`>/7 M?QW\!3WTM]_PS7\#+RXN[^[U+4)9XO%A^T7FHW4U]>S.K>+)@\DES<3.Q(0% MF)"XZ&P;&CH?[0_Q%%I<>!?@3\/O`?PJ?Q,OV:\M_@]X,OD\4ZPTF$*/K\TE M[??,"`)DD6>,_.LD1&\'Z!^A]"?#O]FA/V9?AAXL_:3^,-C:6_CWP5IT][\, M_`]U=Z?=:3H_BO4+5M*\)W6N1V;2I>ZS-XGU98[:VCN7@LXV2X.X75/%>NVTUYXK\1M*C MEY9%L=2G2-B6R_B2Z.=\/(!Q'[3'QTM/#'Q[^*FA2_"[]GS77TCQ/96:ZSXL M^'&F:SXAOU_X0SPC<^;JNI27BS75W&;DVV]T0"&TMXT&(C0!X0/VG;%?#]C+I7@/[7!/>3H=2?0I3<27$8B,D%Y91.F;3> M`O`MYXQ_X2^[\%^$[KQ9:W$EQ;>*+GPYH\_B*WGM=&TVVMIH-;ELVO(9H;1W-] MI%UD0$F"$DDDQ1DD\DDH,DGUH M`\\\1?#SP!XF\1#4O$?@;P?X@U%M-MK=K_6_#.BZK>F"&YE,4!NK^REE,*$G M:A;:N3@"C]`_02'X/?"2,$1_"WXF:3OC:/K5FVG:SI6FZ MMI[7-G.]AJ=C:W]FTT:#I5U=W4H@@B$MQ"_!P'E_\(GX:$:C*I_86EA` M5&Y2%^RX!#`$<<$9H`Z+3X(+6U2&VABMX8BT4<4$:111Q0'[/#&D<8"HD<$4 -4:J``J1JHP%``!__V3\_ ` end