Oceanic Dental Laboratory LLC – FDA 483, Dec 4, 2019

Oceanic Dental Laboratory LLC in Chicago, IL, was inspected from October to December 2019 and received a Form FDA 483 with six observations. The inspection revealed significant deficiencies in the firm's quality system, including a lack of established procedures for acceptance activities, process controls, process validation, corrective and preventive actions, supplier evaluation, and document control. These issues indicate a fundamental breakdown in the firm's ability to ensure product quality and compliance.