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

An FDA pre-announced, routine Good Laboratory Practice (GLP) inspection of North American Science Associates, Inc. (NAMSA) in Northwood, OH, was conducted from August 13 to August 16, 2018. The inspection followed Compliance Program 7342.001, focusing on nonclinical laboratories. Investigators reviewed facilities, operations, quality assurance, personnel, equipment, test article accountability, standard operating procedures (SOPs), and study performance for three specific nonclinical laboratory studies. The review of the studies, including "Oral Toxicity Study in (b) (6) , 7 Day;" "Oral Toxicity Study in (b) (6) , 14 Day;" and "ISO (b) (4) Maximization Sensitization Test," involved examining protocols, raw data, and final reports. Key aspects such as personnel training, quality assurance independence, equipment calibration, animal care, and record-keeping were found to be compliant with regulatory requirements. Notably, the inspection identified no significant objectionable conditions or violations. Consequently, no FDA Form 483, List of Inspectional Observations, was issued, and no refusals or voluntary corrections were reported by the firm. The facility was found to be in good repair and cleanliness, and personnel demonstrated adequate training and adherence to SOPs. The quality assurance unit was deemed independent and effective in overseeing studies. The report concluded with a reminder to management regarding their ongoing responsibility to comply with all FDA regulations, but no specific required actions were mandated as a direct outcome of this inspection.