FDA 483 - Active Medical - December 12, 2019

Restore Medical in Sandy, UT, an HCT/P storage and distributor, was cited for significant deficiencies during an FDA inspection. Observations included a failure to record and review HCT/P storage temperatures, lack of established and approved procedures for handling HCT/Ps, and an absence of a formal personnel training program. These issues indicate a lack of adequate controls and documentation for critical operations.