WARNING LETTER
Susan P. King-Harris, D.P.M.
MARCS-CMS 591682 —
September 09, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
19-HFD-45-08-03
Product:
Biologics
Good Clinical Practice (GCP)
Recipient:
Recipient Name
Susan P. King-Harris, DPM
Susan P. King-Harris, D.P.M.
28100 Grand River Avenue
Suite 301
Farmington Hills
,
MI
48336-5966
United States
Issuing Office:
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Building 51, Room 5364
Silver Spring
,
MD
20993-0002
United States
Dear Dr. King-Harris:
This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between April 29 and May 9, 2019. Investigator Andrace Deyampert, representing FDA, reviewed your conduct as the sponsor-investigator of a clinical investigation,
(b)(4)
of the investigational drug,
(b)(4)
.
This inspection was conducted as a part of 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 human subjects have been protected.
At the conclusion of the inspection, Investigator Deyampert presented and discussed with you Form FDA 483, Inspectional Observations. We acknowledge receipt of your May 22, 2019, written response to the Form FDA 483.
From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your May 22, 2019, written response to the Form FDA 483, we conclude that you did not adhere to the applicable statutory requirements and FDA regulations contained in Title 21 of the Code of Federal Regulations, part 312 [21 CFR 312] governing the conduct of clinical investigations. We wish to emphasize the following:
You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].
As a sponsor-investigator, you are required to ensure that your clinical studies are conducted in accordance with the investigational plan, which requires you to ensure that subjects meet all inclusion and exclusion criteria before their enrollment in the study. You failed to adhere to these requirements.
Specifically, the inclusion and exclusion criteria for the above-mentioned protocol targeted a population of subjects with a specific level of bunion deformity and severity. The inclusion criterion required enrolled subjects to have a bunion severity determined by the intermetatarsal angle (IMA), which was required to be between 10 and 15 degrees. Subjects with an IMA greater than 15 degrees were to be excluded from study participation. The FDA inspection found that you failed to perform IMA measurements for all 14 subjects enrolled in your study between June 2008 and December 2014. Without these protocol-required IMA measurements, you failed to fully evaluate and ensure subjects’ eligibility before their enrollment.
In your May 22, 2019, written response to the Form FDA 483, you acknowledged that you did not adequately screen subjects and did not confirm their eligibility before enrollment. Your response indicated that your overall noncompliance was due to your lack of experience as a clinical investigator and your lack of exposure to the conduct of clinical trials. In addition, you noted that under current Research Institute (that is, Beaumont Health) policies, incidents of noncompliance would be mitigated. You then referred to two standard operating procedures, “Responsibilities of the Principal Investigator” and “Research Administration Oversight,” as supporting evidence.
We are unable to undertake an informed evaluation of your written response because you did not specify corrective actions that you have taken, as a sponsor and clinical investigator, to prevent similar violations in the future. We are concerned that most of the corrective actions taken appear to represent the actions of Beaumont Hospital and do not reflect corrective actions that you personally have taken as a sponsor and clinical investigator.
The eligibility criteria for each clinical investigation are designed to optimize interpretability of collected data and to minimize foreseeable harm to enrolled subjects. Enrollment of subjects who do not meet the eligibility criteria puts subjects’ safety and welfare at risk and raises concerns about the validity and integrity of the data collected during the conduct of a clinical investigation.
This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address these deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.
Within fifteen (15) working days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to explain the violations noted above adequately and promptly may result in regulatory action without further notice.
If you have any questions, please call Sherry G. Bous, Pharm.D., at
240-402-8176
. Your written response and any pertinent documentation should be addressed to:
Sherry G. Bous, Pharm.D.
Director
Division of Enforcement and Postmarketing Safety
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Building 51, Room 5364
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Sincerely yours,
{See appended electronic signature page}
David C. Burrow, Pharm.D., J.D.
Director
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
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This is a representation of an electronic record that was signed
electronically. Following this are manifestations of any and all
electronic signatures for this electronic record.
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/s/
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DAVID C BURROW
09/09/2019 09:32:52 AM
Content current as of:
09/17/2019
Regulated Product(s)
Biologics
Topic(s)
Good Clinical Practice (GCP)