0001104659-13-020552.txt : 20130314 0001104659-13-020552.hdr.sgml : 20130314 20130314130649 ACCESSION NUMBER: 0001104659-13-020552 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20130314 FILED AS OF DATE: 20130314 DATE AS OF CHANGE: 20130314 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Fresenius Medical Care AG & Co. KGaA CENTRAL INDEX KEY: 0001333141 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MISC HEALTH & ALLIED SERVICES, NEC [8090] IRS NUMBER: 000000000 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32749 FILM NUMBER: 13689828 BUSINESS ADDRESS: STREET 1: ELSE-KROENER STRASSE 1 CITY: BAD HOMBURG STATE: 2M ZIP: 61352 BUSINESS PHONE: 011-49-6172-6090 MAIL ADDRESS: STREET 1: ELSE-KROENER STRASSE 1 CITY: BAD HOMBURG STATE: 2M ZIP: 61352 6-K 1 a13-7522_16k.htm 6-K

 

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

 

Pursuant to Rule 13a-16 or 15d-16 of the

Securities Exchange Act of 1934

 

For the month of March 2013

 

FRESENIUS MEDICAL CARE AG & Co. KGaA

(Translation of registrant’s name into English)

 

Else-Kröner Strasse 1

61346 Bad Homburg

Germany

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F   x                             Form 40-F   o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

 

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

 

Yes   o                                          No   x

 

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82

 

 

 



 

On March 14, 2013 Fresenius Medical Care AG & Co. KGaA (the “Company”) issued an Investor News announcing that Fresenius Medical Care North America has received a warning letter from the Food and Drug Administration (FDA).

 

EXHIBITS

 

Exhibit 99.1

 

Investor News Release issued March 14, 2013.

 

2



 

SIGNATURES

 

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 thereunto duly authorized.

 

 

DATE: March 14, 2013

 

 

 

 

 

FRESENIUS MEDICAL CARE AG & Co. KGaA,
a partnership limited by shares, represented by:

 

 

 

FRESENIUS MEDICAL CARE MANAGEMENT AG, its

 

general partner

 

 

 

 

 

 

By:

/s/ RICE POWELL

 

 

 

 

 

 

Name:

Rice Powell

 

 

 

 

 

 

Title:

Chief Executive Officer and

 

 

 

Chairman of the Management Board

 

 

 

of the General Partner

 

 

 

 

 

 

By:

/s/ MICHAEL BROSNAN

 

 

 

 

 

 

Name:

Michael Brosnan

 

 

 

 

 

 

Title:

Chief Financial Officer and

 

 

 

Member of the Management Board

 

 

 

of the General Partner

 

3


EX-99.1 2 a13-7522_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Investor News

Oliver Maier

 

Head of Investor Relations

 

 

 

Fresenius Medical Care

 

Else-Kröner-Straße 1

 

61352 Bad Homburg

 

Germany

 

T +49 6172 609-2601

 

F +49 6172 609-2301

 

oliver.maier@fmc-ag.com

 

www.fmc-ag.com

March 14, 2013

 

 

FDA warning letter on Dialyzer Product Documentation — no effects expected on company guidance for 2013

 

Fresenius Medical Care North America (FMCNA) announced today that it has received a warning letter from the Food and Drug Administration (FDA), asserting that the organization did not conduct adequate design verification studies of its electron beam (E-beam) sterilized polysulfone dialyzers manufactured at its facility located in Ogden, UT and that the process for design validation of these dialyzers has been incomplete. FMCNA received FDA clearance for this product in December 2000. The warning letter does not impose a product recall. FMCNA has continued confidence in the quality of products that are produced in Ogden.

 

“Fresenius Medical Care North America is committed to working with the FDA to resolve the concerns stated in the Letter,” said Rice Powell, CEO, Fresenius Medical Care. “We will address the FDA’s observations as soon as possible. We do not expect any effects on the company’s guidance in terms of revenue and earnings in 2013.”

 

Fresenius Medical Care is the world’s largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 2.2 million individuals worldwide. Through its network of 3,160 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 257,916 patients around the globe. Fresenius Medical Care is also the world’s leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products. For more information about Fresenius Medical Care, visit the Company’s website at www.fmc-ag.com.

 

 

 

 

 

 

 

Disclaimer

This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA’s reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.

 

1


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