FDAnews Device Daily Bulletin

FDA Cites Neo Vision for Design Controls

Feb. 23, 2017

South Korea-based Neo Vision received a warning letter for failing to establish proper design controls, monitor production processes, maintain device history records, and other violations.

Following a May 2016 inspection of Neo Vision’s facility in the central Korean city of Wonju-Si, the FDA said the contact lens manufacturer failed to implement design controls and establish a design history file for some products.

The company also failed to develop, conduct, control, and monitor production processes to ensure that devices conformed to their specifications. A review of 11 device history records for soft contact lenses manufactured for the U.S. market revealed the firm did not have data to show that required testing was performed.

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