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WARNING LETTER

Abington Memorial Hospital, IRC MARCS-CMS 576854 —

Delivery Method:
UPS and Electronic Mail
Product:
Biologics
Recipient:
Recipient Name
G. Chris Christensen III, DO
Recipient Title
Chairman
Abington Memorial Hospital, IRC

1200 Old York Road
Abington, PA 19001
United States

Issuing Office:
Center for Biologics Evaluation and Research

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

Warning Letter

 

CBER-19-02                                                                                      June 24, 2019

 

UPS EXPRESS MAIL & ELECTRONIC MAIL

 

G. Chris Christensen III, DO, Chairman

Abington Memorial Hospital Institutional Review Board

1200 Old York Road

Abington, Pennsylvania 19001

 

Dear Dr. Christensen:

 

This Warning Letter informs you of objectionable conditions observed during a Food and Drug Administration (FDA) inspection of the Abington Memorial Hospital Institutional Review Board (IRB) conducted between February 11, 2019 and February 15, 2019.  The FDA investigator conducted the inspection of this IRB to determine if the IRB’s activities and procedures for the protection of human subjects comply with federal regulations published in Title 21, Code of Federal Regulations (CFR) Part 50- Protection of Human Subjects, Part 56- Investigational Review Boards, and Part 812- Investigational Device Exemptions. The FDA conducted this inspection under the Bioresearch Monitoring Program, which includes inspections designed to review IRB operations for clinical studies of investigational products.  Another objective of the program is to ensure that human subjects are protected from undue hazard or risk during the course of any clinical study.

 

At the end of the inspection, the FDA investigator presented a Form FDA 483, Inspectional Observations for your review and discussed the listed observations with you. To date, the FDA has not received any written response from you concerning the violations noted during the recent inspection.

 

Our review of the establishment inspection report, and its supporting documentation, revealed serious and continuing violations of 21 CFR Part 56- Institutional Review Boards.  The violations include, but are not limited to, the following:

 

1.  Failure to review proposed research at convened meetings at which a majority of members of the IRB are present, including at least one member whose primary concerns are in non-scientific areas. [21 CFR 56.108(c)]

 

Except when an expedited review procedure is used, an IRB is required to review proposed research at convened meetings at which a majority of the IRB members are present, including at least one member whose primary concerns are in non-scientific areas.  Your IRB failed to review proposed research at meetings at which a majority of members were present, including at least one member whose primary concerns are in non-scientific areas, in the following instances:

 

A.  At an IRB meeting on June 1, 2018, your IRB reviewed proposed research without a majority of IRB members present.  The meeting minutes indicate that the IRB reviewed Study (b)(4).  Although the minutes indicate that 8 members were present, this number is overstated since the IRB counted both a voting member ((b)(6)) and the member’s designated alternative ((b)(6)) as present.

 

B.  At a meeting on January 24, 2018, an amendment to Study (b)(4),” was approved by vote without at least one member present whose primary concerns are in non-scientific areas.

 

2.  Failure to prepare and maintain adequate documentation of IRB activities. [21 CFR 56.115(a)(2) and (5)]

 

An IRB is required to prepare and maintain adequate documentation of IRB activities.  This includes preparing and maintaining IRB meeting minutes in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution (21 CFR 56.115(a)(2)).  This also includes preparing and maintaining a list of IRB members identified by name; earned degrees; representative capacity; indications of experience sufficient to describe each member’s chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution (21 CFR 56.115(a)(5)). 

 

Your IRB failed to prepare and maintain adequate documentation of IRB activities in the following instances:

 

A.  Minutes of IRB meetings contain discrepancies with the membership rosters from June 2017 to July 2018. The attendance table in the minutes does not include all the members listed in the voting roster. Therefore, the minutes do not adequately document the presence or absence of these individuals at IRB meetings..

 

Meeting Dates

Discrepancy

6/2/2017, 7/7/2017, 7/28/2017, 9/1/2017, 10/6/2017, 11/3/2017, 12/1/2017, 1/12/2018, 2/1/2018, 3/9/2018, 3/16/2018, 4/6/2018

(b)(6) are listed on the roster as voting members counting towards the quorum number, but are not listed in the attendance table in the minutes

6/1/2018, 7/13/2018

(b)(6) is listed on the roster as a voting member counting towards the quorum number but is not listed in the attendance table in the minutes

 

B.  Minutes of an IRB meeting from March 9, 2018 do not adequately document the IRB’s approval of Study (b)(4).” The study product is a significant risk device, but the meeting minutes indicate both that the study product is not a device and that the study product was determined to be a non-significant risk device.

 

We reviewed previous Establishment Inspection Reports for your IRB and the deficiencies noted are the same or similar for this inspection. It appears that previous corrective actions have not been adequate to prevent recurrence. This letter is not intended to be an all-inclusive list of deficiencies that may exist at your IRB.  Your IRB is responsible for ensuring compliance with the Federal Food, Drug, and Cosmetic Act and applicable regulations.

 

Within fifteen (15) business days of receiving this letter, please provide written documentation of the additional actions you have taken or will take to correct these violations and to prevent the recurrence of similar violations, and a plan to monitor the effectiveness of your corrective actions.  Failure to respond to this letter and to take appropriate corrective action could result in FDA taking regulatory action without further notice to you.  If you do not believe you are in violation of FDA regulations, include your reasoning and any supporting information for our consideration.

 

Your reply should be sent to my attention at the following address:  U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., WO71-G112, Silver Spring, Maryland 20993-0002.  If you have any questions regarding this letter, please contact the Division of Inspections and Surveillance, CBER at 240-402-8928.

 

We also request that you send a copy of your response to the FDA ORA-BIMO East listed below.

 

Sincerely,

/s/

Mary A. Malarkey, Director

Office of Compliance and Biologics Quality

Center for Biologics Evaluation and Research

 

cc:      

Christine Smith, Director

FDA ORA-BIMO East

U.S. Custom House

Room 900

200 Chestnut Street

Philadelphia, PA 19106

 

Lisa K. Buchanan, Acting Director

Division of Compliance Oversight 

Office for Human Research Protections

1101 Wootton Parkway, Suite 200

Rockville, Maryland 20852

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