U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Hikma Farmaceutica, (Portugal) S.A. - Close Out Letter 11/16/15
  1. Warning Letters

CLOSEOUT LETTER

Hikma Farmaceutica, (Portugal) S.A.


Hikma Farmaceutica, (Portugal) S.A.

  

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

Public Health Service
Food and Drug Administration
CENTER FOR DRUG EVALUATION AND RESEARCH
 Office of Manufacturing Quality
Division Drug Quality I
Global Compliance Branch 2
10903 New Hampshire Avenue
Building #51, Room 4235
Silver Spring, MD 20993

TELEPHONE: (301) 796-3275
              FAX: (301) 847-8742

November 16,2015

Riad Ali Mechlaoui
Vice President & Global Head of Injectables
Hikma Farmaceutica, (Portugal) S.A.
Estrada do Rio da Mo, N8, 8A E 8B
Fervenca 2705-906, Terrugem SNT
Portugal

Dear Mr. Mechlaoui:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-15-003 dated October 21, 2014. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

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.


Sincerely,

/S/

Jason F. Chancey
Compliance Officer
Division of Drug Quality I