FDA 483 - Aquavit Life Sciences, Inc. - December 19, 2019

Aquavit Life Sciences, Inc., an initial distributor/importer in New York, NY, was cited with eight observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality system, including a lack of documented procedures for incoming product acceptance, complaint handling, supplier agreements, and overall quality system management. These issues indicate a systemic failure to establish and maintain adequate controls for medical devices like the AQUAGOLD Fine Touch and A.S.A.P! Micro Infusion System.