Integra Neurosciences PR, Inc. - Close Out Letter 1/14/15
- Integra Neurosciences PR, Inc.
Department of Health and Human Services
|Food and Drug Administration|
466 Fernandez Juncos Avenue
San Juan, Puerto Rico, 00901
January 14, 2015
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@example.com.
Director of Compliance
San Juan District Office