Form 8-K FDA closure letter
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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