American Behavioral Research Institute, LLC

Warning LetterOpen

Timea Ciliberti Executive Chair and CEO American Behavioral Research Institute, LLC 2255 Glades Road, Suite 324a Boca Raton , FL 33431-8571 United StatesFEI 3030358101Issued Apr 30, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3030358101.

Violations3

Issue DateApr 30, 2025

Product TypeOther

StatusOpen

Letter Details

Firm: American Behavioral Research Institute, LLC
Location: Timea Ciliberti Executive Chair and CEO American Behavioral Research Institute, LLC 2255 Glades Road, Suite 324a Boca Raton , FL 33431-8571 United States
FEI Number: 3030358101
Country: United States
Issue Date: April 30, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Other
Status: Open

Summary

American Behavioral Research Institute, LLC was cited for failing to submit a required Investigational New Drug (IND) application before conducting a clinical investigation of Relaxium® Sleep, a violation of 21 CFR 312.20(a), 312.20(b), and 312.40(a). The company, acting as both sponsor and clinical investigator, did not adhere to Federal Food, Drug, and Cosmetic Act requirements and applicable regulations governing the conduct of clinical investigations and protection of human subjects under Protocol ABRI-002. The FDA inspection was conducted between April 17 and May 3, 2024, as part of the agency's Bioresearch Monitoring Program to evaluate research conduct and ensure human subject protections.

American Behavioral Research Institute, LLC FDA Warning Letter, April 30, 2025