# FDA EIR - Laura Kooienga, M.D. - May 21, 2021

Source: https://www.keypedia.com/records/eir/laura-kooienga-md/4b828978-fffd-43e3-848a-28ba3f7e731b

> FDA EIR for Laura Kooienga, M.D. on May 21, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Laura Kooienga, M.D.
- Inspection Date: 2021-05-21
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Laura A. Kooienga, M.D.'s clinical investigator site in Denver, CO, was conducted from May 17-21, 2021. This comprehensive review, under compliance program 7348.811 for Clinical Investigators, assessed compliance related to a clinical trial supporting a New Drug Application. The inspection covered various aspects, including subject records, protocol adherence, and investigational product control. While no significant FDA regulatory findings were identified leading to a Form FDA 483, the inspection noted three areas for improvement. These included the need to accurately document the exact time the site became aware of Serious Adverse Events, requiring a provider's signature for changes made by study coordinators to Adverse Event forms, and ensuring all hand-written dates were consistently legible. Additionally, an earlier serious adverse event was reported outside the protocol's 24-hour window, and waivers for two subjects' eligibility were not initially reported to the Institutional Review Board by a previous investigator, though Dr. Kooienga subsequently reported them. Dr. Kooienga acknowledged these observations and committed to implementing the necessary documentation and sign-off procedures and improving date legibility. The site demonstrated cooperation throughout the inspection.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/courtney-r-bratina/3ad4bfd5-d0da-4801-8e90-a5a3ba9291c3)

Company: https://www.keypedia.com/companies/laura-kooienga-md/fc6ca5dc-d803-49f9-9573-f3693c2d5baf

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face