# FDA WARNING_LETTER - Independent Review Consulting, Inc - February 25, 2010

Source: https://www.keypedia.com/records/warning_letter/independent-review-consulting-inc/d4b8fa56-41fe-4096-b364-a41826843ec8

> FDA WARNING_LETTER for Independent Review Consulting, Inc on February 25, 2010. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Independent Review Consulting, Inc
- Inspection Date: 2010-02-25
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On February 8-25, 2010, the FDA inspected Independent Review Consulting, Inc., IRB, identifying objectionable conditions and violations of 21 CFR Part 50, Part 56, and Section 520(g) of the Federal Food, Drug, and Cosmetic Act.

Key violations include:
1.  **Improper Expedited Review:** The IRB approved a significant risk study (b)(4) via expedited review, which is not permitted for studies involving more than minimal risk or those not on the specified list (63 FR 60353). The IRB's response cited a misunderstanding of device status and proposed revisions to Form 4.13B and staff/board training by April 1, 2010. The FDA found this incomplete, requesting revised procedures for determining minimal risk and training dates.
2.  **Inadequate Documentation:** IRB meeting minutes for February 10 and 24, 2009, were inaccurate/incomplete, lacking discussion of controverted issues for the (b)(4) study. The IRB's response indicated a plan to amend minute format for more descriptive language and train staff/board by April 1, 2010. The FDA requested details on format changes, revised procedures, and training dates.
3.  **Failure to Ensure Proper Informed Consent:** This was a repeat violation from a 200

## Related Officers

- [Director](https://www.keypedia.com/people/timothy-a-ulatowski/23498f67-5e0f-4b28-9039-ad64e2dd5b04)

Company: https://www.keypedia.com/companies/independent-review-consulting-inc/797f9f2d-2de9-409c-a812-02ea8067f214

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