Loading…
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.