FDA EIR - North American Science Associates, LLC - February 08, 2017

An FDA inspection of North American Science Associates, Inc., a drug, biologic, and device testing laboratory located in Northwood, OH, was conducted from February 6 to 8, 2017. The inspection, carried out under Compliance Program 7356.002, focused on the firm's control testing operations for drug products, specifically evaluating their quality and laboratory control systems under current Good Manufacturing Practices (cGMP).No formal objectionable conditions were identified, and consequently, no FDA Form 483, Inspectional Observations, was issued. However, the investigator discussed several areas for improvement with management. These included the need for more comprehensive investigations into equipment qualification failures, particularly regarding the justification for applying current deviation information to historical measurements. It was also noted that testing records lacked documented reasons when certain materials were not used after weighing. Suggestions were made to address potential external noise interference during pyrogen testing and to enhance the data supporting the selection of worst-case points for incubator room qualification.Company management was cooperative and committed to implementing corrective actions for all discussed items.