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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Teva Parenteral Medicines - Close Out Letter 10/23/12

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
          Fax (949) 608-4415
 

 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

October 23, 2012

Christine Wells
Vice President, Quality
Teva Parenteral Medicines
19 Hughes Street
Irvine, CA 92618

Dear Ms. Wells:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, W/L 05-10, dated December 11, 2009. Based on our evaluation, it appears that you have addressed the violations 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 the 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 the firm to maintain compliance and will continue to monitor their 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/

Blake Bevill
Director, Compliance Branch
Los Angeles District Office