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

Source: https://www.globalkeysolutions.net/records/483/kalispell-regional-medical-center-inc-irb-4/a9673f41-f46c-410f-9384-858bf659463e

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

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## Details

- Record Type: 483
- Company Name: Kalispell Regional Medical Center, Inc. IRB #4
- Inspection Date: 2019-03-29
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: During an inspection of Kalispell Regional Medical Center, Inc.'s Institutional Review Board (IRB) in Kalispell, MT, the FDA observed a significant procedural error. The IRB improperly used an expedited review process for a research protocol involving an Investigational New Drug (IND) and active study subjects, which did not meet the criteria for expedited review. This indicates a failure to follow appropriate human subject protection regulations.

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822