FDA 483 - Key Distributed Products dba Advanced Vision Technologies, Inc. - May 10, 2019

An FDA inspection of Key Distributed Products dba Advanced Vision Technologies, Inc. in Lakewood, CO, a medical device manufacturer, revealed significant deficiencies across its quality system. The firm lacked adequate procedures for controlling nonconforming product, purchasing controls, and corrective and preventive actions. Additionally, the inspection found an incomplete design history file for its soft contact lens products and undocumented equipment calibrations.