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  5. Hemofarm AD - 04/05/2016
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CLOSEOUT LETTER

Hemofarm AD


Recipient:
Hemofarm AD

United States

Issuing Office:

United States


  

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 II
10903 New Hampshire Avenue
Building #51, Room 6237
Silver Spring, MD 20993

TELEPHONE: (240) 402-2361
             FAX: (301) 847-8742

April 5, 2016

Ms. Tanja Tomić
QA/QC Director Hemofarm STADA SEE
Hemofarm AD
Beogradski put bb
Vrsac, Serbia

Reference: FEI 3006082102

Dear Ms. Tanja Tomić:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter WL 320-12-019 dated June 20, 2012. 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/

Carlos Gonzalez
Compliance Officer
Division of Drug Quality I
Global Compliance Branch II

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