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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sant P. Chawla, M.D. - Close Out Letter 7/29/14

  

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

Public Health Service
 Food and Drug Administration
Silver Spring, MD 20993

 

Sant P. Chawla, M.D.
Sarcoma Oncology Center
2811 Wilshire Blvd., Room 414
Santa Monica, California 90403


Dear Dr. Chawla:

This letter informs you of the findings of a U.S. Food and Drug Administration (FDA) inspection conducted at your site from April 25 to 29, 2011. This inspection is a part of the FDA's Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of the human subjects of those studies have been protected. Mr. James Fleckenstein, representing the FDA, reviewed your conduct of the following clinical investigations:

 

• Protocol (b)(4), "(b)(4)," of the investigational drug (b)(4), performed for (b)(4).

• Protocol (b)(4), "(b)(4)," of the investigational drug (b)(4), performed for (b)(4).

 

The purpose of this inspection was to evaluate your corrective actions taken in response to our Warning Letter [Reference # 10-HFD-45-03-02] to you dated March 17, 2010.

We have completed an evaluation of your corrective actions in response to the Warning Letter noted above. 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.

We appreciate the cooperation shown to Investigator Fleckenstein during the inspection. Should you have any questions or concerns regarding this letter or the inspection, please contact me by letter at the address given below.

 

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
07/29/2014