FDA 483 - Command Medical Products Nicaragua S.A. - December 05, 2013

Command Medical Nicaragua S.A., a medical device manufacturer in Managua, Nicaragua, was inspected by the FDA from December 2-5, 2013. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding internal audit procedures and the validation and documentation of critical sealing processes for Tyvek pouches. These issues indicate a lack of adequate controls to ensure product quality and consistency.