Form 8-K INTEGRA LIFESCIENCES For: Jan 14
�
�
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)) |
�
�
�
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 A�asco, Puerto Rico (the �A�asco 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 A�asco 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 |
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 |
EXHIBIT INDEX
�
Exhibit |
�� | 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 [email protected].
�
Kind regards, |
Edwin Ramos |
Director of Compliance |
San Juan District Office |
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
Integra LifeSciences Announces Resolution of Warning Letter
Related to its Manufacturing Facility in A�asco, 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 A�asco, Puerto Rico (the �A�asco� facility).
The A�asco 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 A�asco 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 A�asco 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
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Integra Lifesciences Holdings Corp - IART
- Faster Recoveries, Improved Security: HTEC and G2 Risk Solutions Join Forces to Advance Bankruptcy Management
- FOLEY BEZEK BEHLE & CURTIS SETTLES "BACK TO THE FUTURE" DELOREAN TRADEMARK INFRINGEMENT CASE WITH NBCUNIVERSAL
Create E-mail Alert Related Categories
SEC FilingsSign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!