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CLOSEOUT LETTER

St Jude Medical CRMD Jun 30, 2014

St Jude Medical CRMD - Close Out Letter 6/30/14


St Jude Medical CRMD

  

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


June 30, 2014


Dr. Eric S. Fain
Group President
St. Jude Medical
Implantable Electronic Systems Division (IESD)
15900 Valley View Court
Sylmar, California, 91342-3577


Dear Dr. Fain:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, W/L 15-13, dated January 10, 2013. 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/

Alonza E. Cruse
District Director
Los Angeles District Office