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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Warner Chilcott Company LLC - Close Out Letter 6/7/13


Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 466 Fernandez Juncos Avenue
San Juan, Puerto Rico, 00901
Telephone: 787-474-9500
FAX: 787-729-6658


June 07, 2013


Return Receipt Requested

Mr. Roger Boissonault
Chief Executive Officer
Warner Chilcott Company, LLC
100 Enterprise Drive
Rockaway, NJ 07866

Dear Mr. Boissonault:

We have completed an evaluation of your firm's corrective actions in response to our Warning Letter 12-SJN-WL-04 dated March 8, 2012. 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 above in the letterhead. You may also contact Mr. Carlos A. Medina, Compliance Officer at telephone number 787-474-9538 or at carlosa.medina@fda.hhs.gov.


Kind regards,


Edwin Ramos
Director of Compliance
San Juan District Office