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))

 

 

 

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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.

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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.

 

Dated: July 10, 2012

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INDEX TO EXHIBITS

 

Exhibit No.		Description
99.1		Letter of the United States Food and Drug Administration dated July 5, 2012.

Exhibit 99.1

 

		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.

 

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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