Devices

13 QS Violations Found at Korea’s Dexcowin Co.

David McFarland

— 2 min read
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An 8/28-8/31/17 FDA inspection at Dexcowin Co., Ltd., Seoul, Korea, found 13 violations of Quality System Regulations, according to a 2/20 Warning Letter. Specific violations cited were: 

  •          failing to establish and maintain adequate procedures for implementing corrective and preventive action;
  •          failing to establish and maintain adequate procedures for validating the device design;
  •          failing to establish and maintain adequate procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation;
  •          failing to adequately ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results according to established procedure;
  •          failing to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services;
  •          failing to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system;
  •          failing to maintain device history records and to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained;
  •          failing to ensure that changes to documents shall be reviewed and approved, while maintaining change records including a description of the change, identification of the affected documents, signature(s) of the approving individual(s), approval date(s), and when the change becomes effective;
  •          failing to establish adequate procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities;
  •          failing of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals;
  •          failing to develop, maintain, and implement written Medical Device Reporting procedures;
  •          failing to establish and maintain adequate records of the results of tests for electronic product radiation safety including the methods, devices, and procedures used in such tests; and
  •          failing to immediately report to the FDA CDRH director an accidental radiation occurrence reported to or otherwise known to the company involving a product introduced or intended to be introduced into commerce by the company.

The letter says that given the serious nature of the violations, the agency is taking steps to refuse entry of the portable dental diagnostic X-ray devices manufactured by the company into the U.S. until the violations are corrected. Dexcowin was told to respond with a list of steps taken to correct the violations and prevent their recurrence, with documentation of the corrections and a timetable for completion.

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