# FDA 483 - HealthEast Institutional Review Board - September 13, 2018

Source: https://www.keypedia.com/records/483/healtheast-institutional-review-board/2beb9579-eadf-4a39-9703-8b521ba5acc6

> FDA 483 for HealthEast Institutional Review Board on September 13, 2018. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HealthEast Institutional Review Board
- Inspection Date: 2018-09-13
- Product Type: devices
- Office Name: Minneapolis District Office
- Summary: During an inspection conducted from September 11-13, 2018, the Food and Drug Administration issued a Form 483 to HealthEast Institutional Review Board, identifying several significant observations related to its operational procedures and compliance. The inspection highlighted three primary areas of concern for the Saint Paul, MN-based IRB.

Firstly, the IRB was observed to lack and fail to follow adequate written procedures for the initial review of drug expanded access studies. Specifically, there were no defined requirements for submissions, and the IRB's file for a drug study lacked necessary FDA documentation, such as the Investigational New Drug (IND) application or approval letter.

Secondly, HealthEast IRB did not possess or adhere to written procedures for promptly reporting instances of serious or continuing noncompliance to the FDA. An internal recognition of serious noncompliance, involving the failure to report two serious adverse events for a study, was not communicated to the FDA, nor was the involved clinical investigator notified.

Finally, the inspection noted a failure by the IRB to notify an investigator after reclassifying a medical device study from non-significant to significant risk. This included a repeat observation regarding the IRB's failure to properly determine the risk level for an investigational medical device when a sponsor's Investigational Device Exemption (IDE) or risk determination was absent.

These observations indicate the need for HealthEast Institutional Review Board to develop and implement robust corrective actions to ensure its procedures align with regulatory requirements for protecting human subjects in research and accurately overseeing clinical investigations.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/kellie-l-thommes/255a1b92-cd56-41f5-9622-82e8a629e153)
- [IRB Chair](https://www.keypedia.com/people/dean-r-huska/4cde4e1f-175c-4d94-b3e6-f6812938090a)

Company: https://www.keypedia.com/companies/healtheast-institutional-review-board/e2ac899b-5e7f-4ab3-9ab4-abb54998c80e

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d