CLOSEOUT LETTER

Linda D. Bosserman October 01, 2014

Recipient:: Linda D. Bosserman; United States

Issuing Office:: United States


Department of Health and Human Services	Public Health Service
	Food and Drug Administration Silver Spring, MD 20993

Linda D. Bosserman, M.D.
Wilshire Oncology Medical Group, Inc.
1502 Arrow Highway
La Verne, CA 91750

Dear Dr. Bosserman:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (Ref: 11-HFD-45-07-01, July 19, 2011). 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 you 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 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,

{See appended electronic signature page}

Constance Cullity, M.D., M.P.H.
Branch Chief
Good Clinical Practice Enforcement Branch
Division of Good Clinical Practice Compliance
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Building 51, Room 5354
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

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This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
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/s/
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CONSTANCE CULLITY
10/01/2014

Department of Health and Human Services