FDA 483 - Tactical Medical Solutions LLC - December 10, 2021

Tactical Medical Solutions LLC, a medical device manufacturer in Anderson, SC, was cited for three observations during an FDA inspection from December 6-10, 2021. The firm failed to establish quality agreements with suppliers, did not document equipment calibrations, and had inadequate procedures and documentation for receiving acceptance activities for their tourniquet products. These issues indicate significant deficiencies in their quality system.