FDA EIR - North American Science Associates Inc. (NAMSA) - December 12, 2014

A routine FDA inspection of North American Science Associates, Inc. (NAMSA), a manufacturer of Class II biological sterilization process indicators, was conducted from December 8-12, 2014. This initial inspection for NAMSA as a medical device manufacturer evaluated compliance with medical device quality system regulations, specifically reviewing areas such as design controls, complaint handling, and corrective and preventive actions. The inspection identified three significant observations, documented on an FDA Form 483. First, the company's procedures for design changes were deemed inadequate, failing to ensure proper review for potential updates to their 510(k) product clearances. Second, the procedures for receiving, reviewing, and evaluating customer complaints were not adequately established, leading to inconsistent complaint processing and delays in health hazard evaluations. Finally, the corrective and preventive action (CAPA) procedures were found insufficient, as a documented corrective action failed to effectively prevent recurrence of a labeling issue in subsequent product lots. NAMSA management acknowledged the observations and committed to correcting all deficiencies. They stated they would provide a formal response to the FDA district office, outlining their proposed corrective actions and the anticipated timelines for their implementation. No additional warnings or regulatory enforcement discussions occurred during the inspection.