Samm Solutions, Inc., d.b.a. BTS Research

Warning LetterOpen

Usama M. Abunadi President and CEO Samm Solutions, Inc., d.b.a. BTS Research 9990 Mesa Rim Road, Suite 100 San Diego , CA 92121 United StatesIssued Oct 20, 2023Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations4

Issue DateOct 20, 2023

Product TypeOther

StatusOpen

Letter Details

Firm: Samm Solutions, Inc., d.b.a. BTS Research
Location: Usama M. Abunadi President and CEO Samm Solutions, Inc., d.b.a. BTS Research 9990 Mesa Rim Road, Suite 100 San Diego , CA 92121 United States
FEI Number: N/A
Country: United States
Issue Date: October 20, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Other
Status: Open

Summary

Samm Solutions, Inc., d.b.a. BTS Research, a nonclinical testing laboratory, failed to comply with Good Laboratory Practice (GLP) regulations during FDA's inspection of drug study protocols conducted between June 27 and July 8, 2022. The company's study director did not adequately ensure that all experimental data were accurately recorded and verified, and failed to document unforeseen circumstances affecting study quality and integrity or implement corrective actions as required under 21 CFR 58.33(b) and (c). These violations compromised the reliability of nonclinical laboratory data submitted to support investigational drug applications.

Samm Solutions, Inc., d.b.a. BTS Research FDA Warning Letter, October 20, 2023