WARNING LETTER

Armstrong County Memorial Hospital MARCS-CMS 692080 — October 29, 2024

Delivery Method:: VIA UPS and Electronic Mail
Reference #:: 24-HFD-45-10-01
Product:: Drugs

Recipient:: Recipient Name

Nichole Geraci, MBA; Recipient Title

President & Chief Executive Officer; Armstrong County Memorial Hospital; 1 Nolte Drive
Kittanning, PA 16201
United States

Issuing Office:: Center for Drug Evaluation and Research (CDER); United States

WARNING LETTER

FDA Ref. No.: 24-HFD-45-10-01

Dear Ms. Geraci:

This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between November 2, 2023, and November 8, 2023, of the Armstrong County Memorial Hospital (ACMH) Institutional Review Board (IRB). Investigator Cynthia L. Rakestraw, representing FDA, conducted the inspection to determine whether the IRB’s procedures for the protection of human subjects complied with FDA regulations contained in Title 21 of the Code of Federal Regulations (21 CFR), parts 50 and 56. These regulations apply to clinical investigations of products regulated by FDA.

This inspection is 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 the human subjects of those studies have been protected.

At the conclusion of the inspection, Investigator Rakestraw presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of the ACMH IRB’s November 13 to 15, 2023, written responses to the Form FDA 483.

From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and the ACMH IRB’s November 13 to 15, 2023, written responses, it appears that the ACMH IRB did not adhere to applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations governing the protection of human subjects.

We wish to emphasize the following:

1. The IRB failed to prepare, maintain, and follow written procedures governing the functions and operations of the IRB [21 CFR 56.108(a) and (b); 21 CFR 56.115(a)(6)].

To fulfill the requirements of the IRB regulations, each IRB must prepare, maintain, and follow written procedures describing the IRB’s functions and operations that are specified in the regulations [21 CFR 56.108(a) and (b); 56.115(a)(6)]. The ACMH IRB failed to adhere to these requirements. Specifically, the ACMH IRB failed to prepare, maintain, and follow such written procedures as follows:

a. The ACMH IRB failed to follow, and to prepare and maintain adequate documentation of, written procedures for reporting its findings and actions regarding initial and continuing review to the investigator and the institution [21 CFR 56.108(a)(1); 21 CFR 56.115(a)(6)].

b. The ACMH IRB failed to follow, and to prepare and maintain adequate documentation of, written procedures for determining which projects require review more often than annually, and which projects need verification from sources other than the investigator that no material changes have occurred since the previous IRB review [21 CFR 56.108(a)(2); 21 CFR 56.115(a)(6)].

c. The ACMH IRB failed to follow, and to prepare and maintain adequate documentation of, written procedures for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the human subjects [21 CFR 56.108(a)(4); 21 CFR 56.115(a)(6)].

d. The ACMH IRB failed to follow, and to prepare and maintain adequate documentation of, written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of: (1) any unanticipated problems involving risks to human subjects or others; (2) any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB; or (3) any suspension or termination of IRB approval [21 CFR 56.108(b); 21 CFR 56.115(a)(6)].

We acknowledge that Item 1b. discussed above was not included on the Form FDA 483 you received, and that your written response therefore does not address this violation.

2. The IRB failed to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings [21 CFR 56.115(a)(2)].

The ACMH IRB is required to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings, which must be in sufficient detail to show attendance at the meetings; actions taken by the ACMH IRB; the votes on these actions, including the number of members voting for, against, and abstaining; the basis for requiring changes in or for disapproving research; and a written summary of the discussion of controverted issues and their resolution. The ACMH IRB failed to adhere to this requirement. Specifically:

a. On May 18, 2021, at a convened meeting, the ACMH IRB reviewed and discussed continuing review for five FDA-regulated studies; however, the meeting minutes do not document the members who attended this meeting.

b. On September 15, 2020, at a convened meeting, the ACMH IRB reviewed and discussed continuing review of an FDA-regulated humanitarian-use device study; however, the meeting minutes do not document the vote on actions taken by the ACMH IRB, including the number of members voting for, against, and abstaining.

In the ACMH IRB’s November 13 to 15, 2023, written responses, the ACMH IRB stated its intent to close the IRB at ACMH and to transfer all responsibility to the IRB at Allegheny General Hospital.

While we acknowledge that the ACMH IRB has stated its intent to close the IRB at ACMH and to transfer all responsibility to the IRB of another institution, your response is inadequate because you did not provide sufficient details about the IRB’s process for transferring IRB review and approval responsibilities for currently approved research studies to another registered IRB. Your response also did not provide sufficient details about the IRB’s plan for the review of research until the ACMH IRB transfers its

responsibilities to another registered IRB, including how the ACMH IRB would address its failure: (1) to prepare, maintain, and follow written procedures describing the IRB’s functions and operations; and (2) to prepare and maintain adequate documentation of IRB meeting minutes. Without this information, we are unable to determine whether the IRB’s corrective action plan is adequate to prevent similar violations in the future.

Please provide a projected timeline for the transfer of the ACMH IRB’s responsibilities to another registered IRB; any process regarding such a transfer; and any written procedures (or any revised written procedures in development) for the review of research until the ACMH IRB transfers its responsibilities to another registered IRB, including (1) procedures for the IRB’s functions and operations, as described in FDA regulations, and (2) procedures for the preparation and maintenance of adequate documentation of IRB meeting minutes.

Failure to prepare and maintain adequate documentation of IRB activities, including written procedures and IRB meeting minutes, raises concerns about the adequacy of the IRB’s review process. Furthermore, inadequate documentation of meeting minutes raises concerns about whether the IRB members maintained a quorum for the duration of the ACMH IRB meetings.

This letter is not intended to be an all-inclusive list of deficiencies related to the ACMH IRB’s procedures or to the ACMH IRB’s review and approval of protocols. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations.

This letter notifies you of our findings and provides you with an opportunity to address the deficiencies described above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions that the ACMH IRB has taken or plans to take to address any violations, and to prevent the recurrence of similar violations in the future. Failure to address this matter adequately may lead to regulatory action. If you believe that the ACMH IRB has complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.

We recommend that you visit the following FDA Web page for information on human subject protections that may assist you in your efforts to come into compliance with FDA regulations: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.

If the IRB has any questions, you may email FDA at CDER-OSI-Communications@fda.hhs.gov.

The IRB’s written response and any pertinent documentation should be addressed to:

Brittany L. Garr-Colón, MPH
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,
{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
10/29/2024 07:12:47 AM