# FDA 483 - Kalispell Regional Medical Center, Inc. IRB #4 - March 29, 2019

Source: https://www.keypedia.com/records/483/kalispell-regional-medical-center-inc-irb-4/71530f8f-83b2-48b2-99af-ed9e8a545e14

> FDA 483 for Kalispell Regional Medical Center, Inc. IRB #4 on March 29, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kalispell Regional Medical Center, Inc. IRB #4
- Inspection Date: 2019-03-29
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: An FDA inspection conducted at Kalispell Regional Medical Center, Inc. IRB #4 from March 27-29, 2019, identified a significant observation regarding its Institutional Review Board (IRB) processes. The primary issue was the IRB's improper use of an expedited review procedure for a research protocol involving an investigational drug. This specific protocol, which included subjects actively receiving investigational drug injections, did not meet the FDA's criteria for expedited review and had not received full board approval within the preceding year, despite having an upcoming expiration date. The study originally received full board approval on March 7, 2018, with approval set to expire on March 7, 2019. The IRB granted approval via an expedited review process on February 1, 2019.

The inspection, documented on an FDA Form 483, highlights a non-compliance with the regulatory framework governing human subject protection and investigational studies under the Federal Food, Drug and Cosmetic Act. Such expedited reviews are intended for specific, low-risk research categories, and their misapplication can compromise the safety and rights of research participants.

As a result of this observation, Kalispell Regional Medical Center, Inc. IRB #4 is expected to respond to the FDA, detailing its objection, if any, and outlining the corrective actions implemented or planned to address the identified deficiency and ensure full adherence to regulatory requirements for IRB review processes in future research studies.

## Related Documents

- [483 - 2019-03-29](https://www.keypedia.com/records/483/kalispell-regional-medical-center-inc-irb-4/a9673f41-f46c-410f-9384-858bf659463e)

## Related Officers

- [Drug Discovery and Biotech Executive](https://www.keypedia.com/people/lloyd-d-payne/8b98c38a-4fbe-465d-bb0a-689bcc6db702)
- [Consumer Safety Officer](https://www.keypedia.com/people/mark-w-jackson/d4c56fee-b58d-4f39-aa7a-996f86282cc3)
- [Grandfather, Fisherman, and loving life!](https://www.keypedia.com/people/mark-babbitt/c093bebb-75e1-4b20-a8d5-72c4e1d81c6d)

Company: https://www.keypedia.com/companies/kalispell-regional-medical-center-inc-irb-4/4e310d81-879a-41ef-b0b8-d922f231dfc3

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913