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

Date of Report (Date of earliest event reported): January 14, 2015

 

 

INTEGRA LIFESCIENCES HOLDINGS CORPORATION

(Exact name of Registrant as specified in its charter)

 

 

 

Delaware		0-26224		51-0317849
(State or other jurisdiction of incorporation or organization)		(Commission File Number)		(I.R.S. Employer Identification No.)

311 Enterprise Drive

Plainsboro, NJ 08536

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (609) 275-0500

Not Applicable

(Former name or former address, if changed since last report)

 

 

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:

 

¨	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.

On January 14, 2015, the United States Food and Drug Administration (the “FDA”) issued a letter to Integra LifeSciences Corporation, a wholly-owned subsidiary of Integra LifeSciences Holdings Corporation (the “Company”) informing the Company that it had addressed the violations in the FDA warning letter dated February 13, 2013 related to the Company’s medical devices manufacturing facility in Añasco, Puerto Rico (the “Añasco Facility”) and that such warning letter had been closed out effective January 14, 2015. A copy of the letter dated January 14, 2015 relating to the resolution of the warning letter matters is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

The press release issued by the Company on January 20, 2015 announcing the resolution of the FDA warning letter related to the Añasco Facility is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

99.1		Letter, dated January 14, 2015, from the United States Food and Drug Administration to Integra LifeSciences Corporation
99.2		Press release issued January 20, 2015

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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 hereunto duly authorized.

 

				INTEGRA LIFESCIENCES HOLDINGS CORPORATION
Date: January 20, 2015				By:		/s/ Glenn G. Coleman
						Glenn G. Coleman
				Title:		Corporate Vice President and Chief Financial Officer

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EXHIBIT INDEX

 

Exhibit Number		Exhibit
99.1		Letter, dated January 14, 2015, from the United States Food and Drug Administration to Integra LifeSciences Corporation
99.2		Press release issued January 20, 2015

Exhibit 99.1

 

				Food and Drug Administration 466 Fernandez Juncos Avenue San Juan, Puerto Rico, 00901 Telephone: 787-729-8500 FAX: 787-729-8826

January 14, 2015

15-SJN-WLCOL-03

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Mr. Peter Arduini

President and CEO

Integra Life-Sciences Corporation

311 Enterprise Drive,

Plainsboro, N.J. 08536

Dear Mr. Arduini:

We have completed an evaluation of your firm’s corrective actions in response to our Warning Letter 13-SJN-WL-03 dated February 13, 2013. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter.

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.

Should you have questions and/or comments regarding this matter, please feel free to contact me at the district office address provided in the letterhead. You may also contact Mrs. Margarita Santiago, Compliance Officer at telephone number (787) 729-8702 or at margarita.santiago@fda.hhs.gov.

 

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Mr. Peter Arduini, President and CEO, Integra Neurosciences P.R., Inc., 15-SJN-WLCOL-03

Page 2

 

Reviewed by:						Date:		1/14/15

CB: WL Legal File

FEI: 3000204775

CMS Case: 392719

EXHIBIT 99.2

News Release

Contacts:

Integra LifeSciences Holdings Corporation

Investor Relations:

Angela Steinway

(609) 936-2268

angela.steinway@integralife.com

Integra LifeSciences Announces Resolution of Warning Letter

Related to its Manufacturing Facility in Añasco, Puerto Rico

Plainsboro, New Jersey / January 20, 2015 – Integra LifeSciences Holdings Corporation (NASDAQ: IART - news) today announced the United States Food and Drug Administration (the “FDA”) has informed the Company that it had addressed the violations in the warning letter relating to its manufacturing facility in Añasco, Puerto Rico (the “Añasco” facility).

The Añasco facility had been operating subject to an FDA Warning Letter dated February 13, 2013 that related to quality systems issues. After concluding its recent inspection of the Añasco facility in September 2014, the FDA determined that the Company’s remediation activities were effective and its quality management system was adequate.

“Over the last few years, we have made significant investments in both people and processes to enhance our global quality assurance programs,” said Peter Arduini, Integra’s President and Chief Executive Officer. “The lifting of the Warning Letter at our Añasco facility is evidence of the progress we have made in improving our quality systems throughout the Company.”

Please refer to the Form 8-K filed concurrently with this press release for additional information.

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions, including leading regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies, and spine hardware and orthobiologics. For more information, please visit www.integralife.com