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 registrants 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 |
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Investor News Release issued March 14, 2013. |
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
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FRESENIUS MEDICAL CARE AG & Co. KGaA, | ||
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FRESENIUS MEDICAL CARE MANAGEMENT AG, its | ||
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general partner | ||
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By: |
/s/ RICE POWELL |
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Name: |
Rice Powell |
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Title: |
Chief Executive Officer and |
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Chairman of the Management Board |
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of the General Partner |
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By: |
/s/ MICHAEL BROSNAN |
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Name: |
Michael Brosnan |
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Title: |
Chief Financial Officer and |
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Member of the Management Board |
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of the General Partner |
Exhibit 99.1
Investor News |
Oliver Maier |
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Head of Investor Relations |
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Fresenius Medical Care |
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Else-Kröner-Straße 1 |
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61352 Bad Homburg |
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Germany |
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T +49 6172 609-2601 |
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F +49 6172 609-2301 |
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oliver.maier@fmc-ag.com |
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www.fmc-ag.com |
March 14, 2013 |
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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 FDAs observations as soon as possible. We do not expect any effects on the companys guidance in terms of revenue and earnings in 2013.
Fresenius Medical Care is the worlds 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 worlds leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products. For more information about Fresenius Medical Care, visit the Companys 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. KGaAs 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.