FDA EIR - North American Science Associates Inc - August 16, 2018

An FDA inspection of North American Science Associates, Inc. (NAMSA), a nonclinical laboratory in Northwood, OH, was conducted from August 13-16, 2018. This routine, pre-announced inspection was performed under Compliance Program 7348.808, focusing on Good Laboratory Practice (GLP) for nonclinical laboratories. The inspection scope included facilities, operations, quality assurance, personnel, equipment, test article accountability, standard operating procedures (SOPs), and study performance, with a detailed review of three nonclinical studies. Investigators verified compliance with regulatory requirements, including 21 CFR 58.81 for SOP adequacy, 21 CFR 58.120 for protocol elements, and 21 CFR 58.185 for final report content. Crucially, the inspection identified no objectionable conditions. Consequently, no FDA-483, List of Inspectional Observations, was issued, and no significant violations or issues were observed. Management was reminded of their responsibility to comply with all FDA regulations, but no specific required actions or voluntary corrections were mandated by the agency. The findings indicate NAMSA's operations were in good standing regarding GLP compliance.