FDA WARNING_LETTER - Teneo IRB - March 18, 2009

The FDA issued a Warning Letter to Teneo IRB on November 10, 2009, following an inspection from March 12-18, 2009, which revealed significant violations of 21 CFR Part 56 governing IRB operations and human subject protection.

The primary violation was the failure to prepare and maintain adequate documentation of IRB activities [21 CFR § 56.115(a)(1) and (2)]. The inspection uncovered discrepancies between "Teneo Minutes from Teneo" (provided by Teneo) and "Teneo Minutes from (b)(4)" (obtained from a third party), with the latter documenting numerous IRB activities (e.g., protocol approvals, continuing reviews, adverse event evaluations, SOP revisions, emergency approvals, pediatric subject discussions) not present in the former. Specific examples included omitted individual member votes, unrecorded serious adverse event discussions, unlisted SOP approvals and new member additions, and no records for several meetings. Teneo IRB also failed to maintain copies of issued approval letters and documentation of emergency approval requests. Inconsistencies regarding pediatric subject participation in the (b)(4) study protocol and consent forms were also noted.

As a result, the FDA immediately withheld approval of all new studies reviewed by Teneo IRB and prohibited new subject enrollment in ongoing studies subject to 21 CFR Part 56. These restrictions remain until adequate corrections are confirmed. Teneo IRB must notify the