FDA 483 - Atlanta Hyperbaric Center LLC - October 10, 2019

Atlanta Hyperbaric Center LLC, a medical device manufacturer in Powder Springs, GA, was cited for significant deficiencies across its quality management system. The inspection revealed inadequate procedures for complaint handling, a lack of understanding and implementation of corrective and preventive actions (CAPA), and insufficient controls over production processes, including release testing and documentation for used devices. These issues indicate systemic problems with the firm's compliance with quality system regulations.