FDA 483 - Steiner Biotechnology LLC - June 28, 2019

An FDA inspection of Steiner Biotechnology, LLC in Henderson, NV, a nonclinical laboratory, revealed significant deficiencies in their Good Laboratory Practice (GLP) compliance. Observations included multiple deviations from study protocols, use of unqualified personnel for surgical procedures, and a complete lack of quality assurance unit oversight for ongoing studies. The firm also failed to maintain adequate records, provide proper animal housing, and ensure proper specimen identification and data archival.