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  5. Faro Ted Owiesy - 564421 - 11/16/2018
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WARNING LETTER

Faro Ted Owiesy MARCS-CMS 564421 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
Ref: 18-HFD-45-10-01

Recipient:
Recipient Name
Faro Ted Owiesy, M.D.
Faro Ted Owiesy
Corona Doctors Medical Clinics, Inc.

802 Magnolia Avenue
Suite 106
Corona, CA 92879-3104
United States

Issuing Office:
Center for Drug Evaluation and Research

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


Dear Dr. Owiesy:

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 June 22 and June 27, 2018.  Ms. Denise L. Burosh, representing FDA, reviewed your conduct as the clinical investigator and authorized representative of the sponsor (b) (4) of a clinical investigation, (b) (4) of the investigational drug consisting of a combination of (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, Ms. Burosh presented and discussed with you Form FDA 483, Inspectional Observations.  We acknowledge receipt of your July 3, 2018, written response to the Form FDA 483.

From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated July 3, 2018, we conclude that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.  We wish to emphasize the following:

1. As the authorized representative of the sponsor Corona Doctors Medical Clinics, Inc., you violated a clinical hold by giving subjects an investigational drug after FDA issued an order to delay a proposed clinical investigation [21 CFR 312.42(a)].

A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation.  The clinical hold order may apply to one or more of the investigations covered by an investigational new drug application (IND).  When a proposed study is placed on clinical hold, subjects may not be given the investigational drug.

Your IND (IND (b) (4)), which included the inspected study, was placed on full clinical hold during FDA’s teleconference with you on August 10, 2017, for insufficient information to assess risks to human subjects of the proposed study [21 CFR 312.42(b)(1)(iv)].  During the teleconference, you stated that you understood you could not initiate the trial.  As a follow-up to this teleconference, FDA sent you a Full Clinical Hold letter dated September 7, 2017, in which FDA reiterated that no studies under IND (b) (4) could be initiated from the date of the August 10, 2017, teleconference, and that the IND was placed on clinical hold because of insufficient information to assess risks to human subjects of the proposed study [21 CFR 312.42(b)(1)(iv)].  You sent FDA a response to the Full Clinical Hold letter on October 10, 2017.  FDA replied on November 17, 2017, with a letter refusing to remove the clinical hold because your response did not address all the issues identified in the Full Clinical Hold letter.
 
You violated the full clinical hold order when you administered the investigational drug consisting of a combination of (b) (4) to the following six subjects participating in an investigation that was contemporaneously subject to a clinical hold: 

 

Subject
Treatment Date(s)
(b) (6)
August 21, 2017
(b) (6)
August 18, 2017, and
August 21, 2017
(b) (6)
August 10, 2017
(b) (6)
August 18, 2017
(b) (6)
August 14, 2017
(b) (6)
August 21, 2017

 

These subjects all received investigational drug after the clinical hold was placed on your proposed study on August 10, 2017.  Notably, in the case of Subject (b) (6), you administered the investigational drug only a few hours after the teleconference with FDA informing you of the full clinical hold. 
 
In your July 3, 2018, written response, you acknowledged treating subjects after your study was placed on full clinical hold.  You noted that after the teleconference with FDA on August 10, 2017, notifying you of the full clinical hold, you “did understand to wait for explanation of the extent of deficiencies in writing.”  You explained that after you received the Full Clinical Hold letter on September 13, 2017, you did not initiate any treatment with investigational drug after that date.  However, you stated that study staff continued subject recruitment without your knowledge.  You offered to discard the data from the treated subjects and indicated that you may hire a new monitor. 
 
Your written response is inadequate because you failed to provide an explanation why you continued to treat subjects with investigational drug despite your acknowledgement during the August 10, 2017, teleconference that alerted you to the full clinical hold.  Your written response is also inadequate because you did not provide a corrective action plan to prevent the recurrence of similar violations in the future.

2. You administered an investigational new drug to human subjects without an effective Investigational New Drug application (IND) [21 CFR 312.40(d)].

An IND goes into effect 30 days after FDA receives the IND unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold, or notifies the sponsor that a clinical investigation may begin prior to the 30 days.  See 21 CFR 312.40(b).  An investigator may not administer an investigational new drug to human subjects until the IND goes into effect.

FDA received your IND on July 17, 2017.  Prior to the 30-day requirement and without any communication by FDA that the clinical investigation may begin, you administered investigational drug to Subject (b) (6) on July 21, 2017, and you administered investigational drug to Subject (b) (6) on August 3, 2017.  These two subjects received investigational drug when the IND was not in effect.  You also administered the investigational drug to six subjects after the IND had been placed on full clinical hold, as described in Item 1 above.

In your July 3, 2018, written response, you did not address this observation or provide any corrective actions to prevent the recurrence of similar violations in the future.

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 adequately and promptly explain the violations noted above may result in regulatory action without further notice. 

If you have any questions, please contact Adam Donat, M.S., at 301-796-5316.  Your written response and any pertinent documentation should be addressed to:

Adam Donat, M.S.
Branch Chief
Compliance Enforcement Branch
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 5352
10903 New Hampshire Avenue
Silver Spring, MD  20993 
 

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
11/16/2018