FDA EIR - North American Science Associates, LLC - October 06, 2015

An FDA inspection was conducted at North American Science Associates, Inc. (NAMSA) in Northwood, OH, from September 29 to October 6, 2015. This comprehensive inspection was a routine Good Laboratory Practice (GLP) data audit and surveillance, carried out under the Bioresearch Monitoring-Good Laboratory Practice (Nonclinical Laboratories) regulatory framework (CP 7348.808). The scope of the inspection covered the firm's facilities, operations, personnel, equipment, test article controls, and study performance, including data integrity for multiple audited studies. These studies encompassed various toxicity, genotoxicity, implantation, and other GLP studies on different animal models. Importantly, the inspection identified no objectionable conditions, and consequently, no Form FDA-483 (Inspectional Observations) was issued. The report noted that management was cooperative, and no refusals were encountered. This positive outcome indicates that NAMSA's nonclinical laboratory operations were found to be in compliance with applicable GLP regulations during this inspection period, requiring no specific corrective actions from the agency.