Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail
-

Alkis Togias, M.D./Johns Hopkins Asthma & Allergy Clinic, Baltimore, MD.: FDA 483 Inspectional Observations; (Baltimore) 06/28/2001

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

 DISTRICT OFFICE ADDRESS AND PHONE NUMBER
900 Madison Avenue
Baltimore, MD 21201
410-962-3396
DATE(S) OF INSPECTION
6/18,19,20,21,28/01
FEI NUMBER
3003350724
 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Alkis Togias, MD, Associate Professor of Medicine
FIRM NAME
Johns Hopkins Asthma & Allergy Clinic
STREET ADDRESS
5501 Hopkins Bayview Circle
CITY, STATE AND ZIP CODE
Baltimore, MD 21224
TYPE OF ESTABLISHMENT INSPECTED
Clinical Investigator

DURING AN INSPECTION OF YOUR FIRM, I OBSERVED:

The following observations are related to RPM No.: AACOO-07-26-02, entitled, "Mechanisms of Deep Inspiration-Induced Airway Relaxation."

  1. This sponsor/clinical investigator failed to submit an IND to the FDA prior to conducting this clinical investigation, which involved the administration of hexamethonium bromide by inhalation to 3 human subjects.

     

  2. The sponsor/clinical investigator failed to report an unanticipated adverse event to the IRB.

    The first subject in the study,     , was administered hexamethonium on 4/23/01. She developed a persistent cough from 4/25/01 till 5/3/01. The IRB was not notified of this event.

  3. Failure to follow the protocol in that the protocol stated that hexamethonium would be administered by inhalation, when in fact; hexamethonium and sodium bicarbonate were actually administered to the second and third subjects.

     
  4. This sponsor/clinical investigator made changes to the approved protocol, dated 9/18/00, without notifying the IRB and without IRB approval, for example:

    a.The sponsor/clinical investigator added sodium bicarbonate to the hexamethonium to change its pH, for the second and third subjects, without notifying and obtaining approval from the IRB. There were no records available for review to determine how much sodium bicarbonate was added.

    b. The protocol approved by the IRB, dated 9/18/00, stated that the "subjects will be premedicated with either hexamethonium, or its vehicle (normal saline), by inhalation." The clinical investigator administered 4.5% hyperosmolar saline instead of the normal saline.

  1. Failure to obtain effective informed consents from subjects, in that the sponsor/clinical investigator failed to disclose that inhalation administration of hexamethonium was an experimental use of the drug.

 SEE REVERSE OF THIS PAGE

 EMPLOYEE(S) SIGNATURE EMPLOYEE(S) NAME AND TITLE (Print or Type)
J. Diann Shaffer, Investigator

 DATE ISSUED
6/28/01

FORM FDA 483 (8/00) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS PAGE 1 OF 1 PAGES

 

Return to: Page Top | EFOI Reading Room Start

-
-