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# Quality System Violations at Korea’s Neo Vision
- URL: https://www.fdaweb.com/quality-system-violations-at-koreas-neo-vision/
- Published: 2017-02-07T12:00:00.000Z
- Updated: 2026-09-14T22:04:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137918

A 5/9-5/12/16 FDA inspection at Neo Vision, Wonju-Si, Gangwon-Do, Korea, found violations of Quality System Regulations in the firm’s manufacturing of daily wear soft contact lenses. A just-released 9/14/16 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm539957.htm?ref=fdaweb.com) says that violations shown on an FDA-483 included: 

- failing to establish and maintain procedures to control the device design to ensure that specified design requirements are met;
- failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications;
- failing to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record; and
- failing to develop, maintain, and implement written Medical Device Reporting procedures.

The firm’s responses to the inspection observations were inadequate. The agency says that due to the serious nature of the violations, it is refusing entry of the firm’s products into the U.S. through detention without physical examination until the violations are corrected.

Neo was told to respond with a list of steps taken to correct the violations and prevent their recurrence, along with documentation of each step and a timetable for completion.