Inspections, Compliance, Enforcement, and Criminal Investigations
Allen, Mark S., M.D. 28-Jan-02
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville, MD 20850
Via Federal Express
JANUARY 28, 2002
Mark S. Allen, M.D.
1127th Street NE
Rochester, Minnesota 55906
Dear Dr. Allen:
This Warning Letter informs you of objectionable conditions found during a Food
Drug Administration (FDA) inspection conducted at your clinical site and requests from you a prompt reply informing us of your corrective actions. You participated as a clinical investigator in a study entitled [redacted] to investigate the device [redacted]. Data from the study conducted at your site was submitted to the FDA in support of the
premarket approval application [redacted].
During the period of November 14 through December 6, 2001, you were visited by
William E. Keer, an investigator FDA?s Minneapolis District Office. The purpose of Mr. Keer?s visit was to conduct an inspection to determine whether your activities and procedures as a clinical investigator for the [redacted] study complied with applicable regulations. This product is a device as that term is defined under Section 201 (h) of the Federal Food, Cosmetic Act (the Act).
This inspection was conducted a program designed to ensure that data and
information contained in application for Investigational Device Exemptions (IDE),
Premarket Approval (PMA), and premarket Notification (510(k)) submissions are
scientifically valid and accurate. other objective of the program is to ensure that
human subjects are protected from undue hazard or risk during the course of scientific
We have completed our review he inspection report submitted by the Minneapolis
significant violations of the requirements under Title 21 CFR, Part 50 - Protection of Human Subjects; 21 Boards; and 2 1 CFR Part 8 12 - Investigational Device
Exemptions. These violations are listed on the Form FDA 483 "Inspectional
Observations," which was presented to and discussed with you at the conclusion of the
inspection. The violations note the Form FDA 483 and our subsequent review of the
inspection report are summarize below:
Failure to prepare and submit complete, accurate, and timely reports (21 CFR
You failed to prepare and submit to the institutional review board timely reports. For
example, two study subjects died [redacted] and [redacted] and one study subject [redacted] was hospitalized for renal failure. These unanticipated adverse device effects were not submitted to the institutional review board in a report as soon as possible and within 10 working days after first learning of the effect.
Failure to obtain legally effective informed consent from study subjects (21 CFR
Part 50 and 21 CFR 812.100).
You failed to ensure that legally effective informed consent was obtained. For
example, study subjects with randomization numbers [redacted] through [redacted] version of the consent form.
Failure to maintain accurate, complete, and current records relating to the
investigation (21 CFR 812.140(a)).
- You failed to maintain documents evidencing informed consent. For example, original informed consent forms for study subjects [redacted] and [redacted] were lost and therefore, not found in the study records.
- You failed to record completely and accurately treatment of study subjects with concomitant medications. Missing from the concomitant medications and treatment reports were the reasons for the prescriptions, dates medications started and discontinued.
- You failed to maintain test article accountability records. For example, test article accountability documents were not complete due to missing dates received, number received, lot numbers, and subject identifications.
Failure to control the use of devices under investigation (21 CFR 812.100 and
You failed to control the use of devices under investigation and maintain test article
accountability. For example, the document Investigator Accountability/Disposition
Record was not maintained. Some time after August 13, 2000 the form was not kept
current. The blocks for date received, number received, lot number and subject
identification were left blank from September 5 to October 13, 2000.
The violations listed above are not intended to be an all-inclusive list of deficiencies at
your site. As a clinical investigator, it is your responsibility to ensure that investigations
that you participate in are conducted in accordance with applicable FDA regulations. To
assist you, we have enclosed a copy of the FDA Information Sheets, guidance for clinical
Please advise this office, in writing, within fifteen working days of receipt of this letter,
of the specific steps that you have taken to correct these violations and other violations
known to you, and to prevent the recurrence of similar violations in current or future
studies. Failure to respond may result in regulatory action, including disqualification,
without further notice.
You should direct your response to the Food and Drug Administration, Center for
Devices and Radiological Health, Office of Compliance, Division of Bioresearch
Monitoring, Program Enforcement Branch II (HFZ-312), 2098 Gaither Road, Rockville,
Maryland 20850, Attention: Viola Sellman, Branch Chief.
A copy of this letter has been sent to our Minneapolis District Office, 240 Hennepin
Avenue, Minneapolis, Minnesota 55401. We request that a copy of your response be sent
to that office as well.
Office of Compliance
Center for Devices and Radiological Health