UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
April 22, 2015
Date of Report (Date of earliest event reported)
AGILENT TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
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Delaware | | 001-15405 | | 77-0518772 |
(State or other Jurisdiction | | (Commission File Number) | | (IRS Employer |
of Incorporation) | | | | Identification No.) |
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5301 Stevens Creek Boulevard
Santa Clara, CA 95051
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: (408) 345-8886
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On April 20, 2015, Agilent Technology, Inc.’s subsidiary, Dako Denmark A/S (together the “Company”), received a close-out letter from the U.S. Food and Drug Administration (“FDA”) informing us that it had evaluated the Company’s corrective actions and that it appeared that the Company had addressed the violations in the FDA warning letter dated August 21, 2013, related to compliance with current Good Manufacturing Practices (“cGMP”) of the Quality System Regulations at our Glostrup facility. The FDA stated that it will assess the adequacy and sustainability of the corrective actions in future inspections.
The Company issued a press release on April 22, 2015, announcing the resolution of the FDA warning letter related to the Glostrup facility. A copy of the press release is attached as Exhibit 99.1 to this report and incorporated by reference herein. The information contained in this report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of Section 18. Furthermore, the information contained in this report shall not be deemed to be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, as amended.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following is furnished as an exhibit to this report and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended:
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Exhibit No. | | Description | | | |
99.1 |
| | Press release dated April 22, 2015, regarding FDA close-out letter.
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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.
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| AGILENT TECHNOLOGIES, INC. |
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| By: | /s/ Michael Tang |
| Name: | Michael Tang |
| Title: | Vice President, Assistant General Counsel and |
| | Assistant Secretary |
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Date: April 22, 2015 | |
EXHIBIT INDEX
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Exhibit No. | | Description | | | |
99.1 |
| | Press release dated April 22, 2015, regarding FDA close-out letter.
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Exhibit 99.1
EDITORIAL CONTACTS:
Michele Drake
+1 408 345 8396
michele_drake@agilent.com
Victoria Wadsworth-Hansen
+45 2933 6980
victoria.wadsworth-hansen@agilent.com
INVESTOR CONTACT:
Alicia Rodriguez
+1 408 345 8948
alicia_rodriguez@agilent.com
Agilent Technologies Announces Resolution to U.S. FDA Warning Letter for Dako Denmark
FDA Completes Evaluation in Denmark, Indicates Issues Have Been Addressed
SANTA CLARA, Calif., April 22, 2015 - Agilent Technologies Inc. (NYSE: A) today announced that its subsidiary, Dako Denmark A/S, has received a close-out letter from the U.S. Food and Drug Administration with respect to the warning letter issued Aug. 21, 2013. The FDA informed Dako Denmark that it has completed its evaluation of Dako’s corrective actions and that it appears Dako has addressed the violations contained in the warning letter.
The warning letter, issued by the FDA’s Center for Devices and Radiological Health, focused on Dako’s quality management processes for complaint handling, corrective and preventive actions, statistical techniques and process validation. The letter was the result of an inspection the FDA performed at Dako’s facility in Glostrup, Denmark, in March 2013.
“We are pleased with this outcome,” said Agilent President and CEO Mike McMullen. “It underscores our commitment to maintaining a compliant and superior quality management system, and to delivering products that are of the highest quality.”
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A), a global leader in life sciences, diagnostics, and applied chemical markets, is the premier laboratory partner for a better world. Agilent works with customers in more than 100 countries, providing instruments, software, services, and consumables for the entire laboratory workflow. Agilent generated revenues of $4.0 billion in fiscal 2014. The company employs about 12,000 people worldwide. Information about Agilent is available at www.agilent.com.
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