# FDA EIR - Advarra IRB - May 27, 2021

Source: https://www.keypedia.com/records/eir/advarra-irb/b6fe5d28-e806-4300-b924-8da21434490a

> FDA EIR for Advarra IRB on May 27, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Advarra IRB
- Inspection Date: 2021-05-27
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: An FDA "for-cause" inspection of Advarra IRB, located in Columbia, MD, took place from May 20-27, 2021. Conducted under Compliance Program 7348.809 and guided by 21 CFR Parts 50 and 56, the inspection primarily focused on assessing the IRB's compliance, particularly its determination of risk for a SARS-COV-2 Antigen Rapid Qualitative Test product.

While no formal FDA-483 "Inspectional Observations" were issued, the inspection highlighted several discussion items with Advarra management. These included ensuring sponsor compliance with 21 CFR 809.10(c), a gap in written procedures concerning the regulatory framework for conventional food products or Generally Recognized as Safe (GRAS) substances (specifically, failing to consider an Investigational New Drug application for a food product studied for disease), and a failure to report the disbanding of an acquired IRB Company (IRBCo) within the required 30 days. Additionally, inaccurate study-related contact information was noted in Informed Consent documents. Advarra management acknowledged these issues and committed to implementing corrective and preventive actions.

## Related Officers

- [recipient](https://www.keypedia.com/people/doug-fulton/070e2e10-56b2-4191-adda-c1d2940340e1)
- [company_representative](https://www.keypedia.com/people/lauri-carlile/110d403e-04fe-4359-94e6-4715cd86988d)
- [Consumer Safety Officer/BIMO Investigator](https://www.keypedia.com/people/david-l-chon/227b9c21-14c4-442b-bdc3-ad167567fd92)
- [company_representative](https://www.keypedia.com/people/judith-carrithers/354e6540-4aab-4966-b877-12fcc785da3f)
- [company_representative](https://www.keypedia.com/people/michele-russell-einhom/3da1b89d-3d8d-49bf-8ce1-33e376f231ea)

Company: https://www.keypedia.com/companies/advarra-irb/d136cac1-c58c-409f-ae40-fe053d284edb

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7