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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Memorial Hospital of South Bend, IRB - Close Out Letter 4/28/14

  

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

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

 

Mr. Kreg Gruber, President
Memorial Hospital of South Bend
615 North Michigan Street
South Bend, IN 46601


Dear Mr. Gruber:

We refer to the Institutional Review Board (IRB) inspection that Ms. Myra K. Casey conducted, representing the Food and Drug Administration (FDA), on November 6, 2013 at the Memorial Hospital of South Bend. The purpose of this inspection was to determine whether the IRB was compliant with the regulatory requirements for the protection of human subjects as specified in Title 21 of the Code of Federal Regulations (CFR), parts 50 and 56. These regulations apply to clinical investigations of products regulated by FDA.

During the inspection, Ms. Casey evaluated the IRB’s corrective actions in response to the FDA Warning Letter [Reference #12-HFD-45-09-01] dated September 21, 2012. Based on that evaluation, it appears that the IRB has taken appropriate corrective actions to address the violations contained in the Warning Letter.

This letter does not relieve the IRB from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its associated regulations or with other relevant legal authority. The FDA expects the IRB to maintain compliance with all regulatory requirements. This letter will not preclude any future regulatory action should violations be identified during a subsequent inspection or through other means.

For helpful information on human subject protections, please visit the following FDA web page:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

We appreciate the cooperation shown to FDA Investigator Casey during the inspection. Should you have any questions or concerns regarding this letter or the inspection, please contact me at 301-796-5553, or by letter at the address given below.

 

Sincerely yours,

{See appended electronic signature page}

Catherine Parker, RN
Team Lead, Human Subject Protection Branch
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Bldg. 51, Room 5210
10903 New Hampshire Avenue
Silver Spring, MD 20993

 

cc: Ms. Alicia Dombkowski
      IRB Chairperson
      Memorial Hospital of South Bend
      615 North Michigan Street
      South Bend, IN 46601

 

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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/
----------------------------------------------------
CATHERINE E PARKER
04/28/2014