Inspections, Compliance, Enforcement, and Criminal Investigations
Pharmaceutical Company Jelfa SA - Close Out Letter 2/28/13
| Public Health Service Food and Drug Administration |
| CENTER FOR DRUG EVALUATION AND RESEARCH Office of Manufacturing and Product Quality Division International Drug Quality International Compliance Branch 10903 New Hampshire Avenue Building #51, Room 4237 Silver Spring, MD 20993 TELEPHONE: (301) 796-4839 FAX: (301) 847-8742 |
Department of Health and Human ServicesFebruary 28, 2013
Mr. Marek Wojcikowski
President of the Board
Pharmaceutical Company Jelfa SA
21 Wincentego Pola Str., 58-500
Jelenia Góra, Poland
Reference: FEI 3004680543
Dear Mr. Wojcikowski:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-11-016 dated July 14, 2011. 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/
Rafael Arroyo
Compliance Officer
Division of International Drug Quality
