FDA WARNING_LETTER - Travanti Pharma, Inc. - February 28, 2008

An FDA inspection conducted between February 19 and 28, 2008, at Travanti Pharma, Inc., identified significant violations in the conduct of clinical investigations for an investigational device-drug combination product. The inspection, part of the Bioresearch Monitoring Program, revealed the firm failed to adhere to applicable statutory requirements and FDA regulations. Key deficiencies included the failure to submit an Investigational New Drug (IND) application for studies subject to 21 CFR 312.2(a), 312.20(a), and 312.40(a). Additionally, Travanti Pharma failed to obtain investigator statements (Form FDA 1572) as required by 21 CFR 312.53(c)(1), did not select a qualified monitor for the investigations (21 CFR 312.53(d)), and failed to maintain adequate records for investigational drug disposition (CFR 312.57(a)). The firm also neglected to maintain complete and accurate records of investigators' financial interests under 21 CFR Part 54, as described in 21 CFR 312.57(b). While Travanti Pharma acknowledged the IND requirement and committed to future compliance, their response lacked detailed corrective action plans. The FDA requires a written response within fifteen working days outlining specific actions, including corrective action plans and SOPs, to prevent recurrence. Failure to adequately address these violations may lead to further regulatory action.