FDA EIR - North American Science Associates, LLC - May 26, 2011

An FDA inspection of North American Science Associates Inc (NAMSA) in Northwood, OH, occurred from May 23-26, 2011. This inspection focused on non-clinical laboratory operations, specifically cytotoxicity, genotoxicity, and lymph node assays for a stent and delivery system, conducted under the Good Laboratory Practices (GLP) regulatory framework as per assignment CP7348.808. Although no formal Inspectional Observations form was issued, the FDA investigator made several verbal observations. Key issues included an error in a cytotoxicity study report, which incorrectly stated cell confluence and lacked corresponding data recording; a discrepancy in the genotoxicity study protocol regarding a reagent supplier; and insufficient specificity in the test article description for a delivery system, alongside an unclarified lot number discrepancy for a device in cytotoxicity testing. Additionally, the inspection noted unused 'pigtails' connected to animal room drinking water lines, creating "dead legs." In response to these findings, NAMSA's management committed to entering all verbal observations into their deviation system for review and appropriate corrective action. During the inspection, the study director promptly amended the cytotoxicity report to reflect correct cell conditions and provided written clarification for the lot number issue. The firm also declined to provide the key to sponsor identity and IACUC meeting minutes. This inspection highlights the importance of precise documentation and facility maintenance in GLP-compliant non-clinical testing.