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

An FDA inspection conducted at Aquavit Life Sciences, Inc. from October 23 to December 19, 2019, identified eight significant observations related to the company's quality system. The primary issues highlighted a systemic lack of documented procedures and practices essential for regulatory compliance. Specifically, the inspection found that the company failed to document the acceptance or rejection of incoming products, including the AQUAGOLD Fine Touch device. Complaint handling procedures were inadequate, with no documented investigations for 32 complaints logged since 2014, including one serious adverse event. Furthermore, there were no formal agreements with foreign contract manufacturers or sterilizers to notify Aquavit Life Sciences of product or service changes, and supplier qualification records were absent. The FDA also noted the absence of fundamental quality system procedures for areas such as supplier evaluations, internal audits, document control, employee training, management reviews, and corrective and preventive actions. The Medical Device Reporting (MDR) procedure lacked crucial definitions and a standardized review process, and procedures for controlling non-conforming products were not adequately established. Finally, the facility lacked procedures for finished device acceptance and a designated storage area for rejected items, and personnel performing quality system functions lacked necessary background and training. Aquavit Life Sciences, Inc. has pledged to correct all identified observations to ensure adherence to quality system requirements.