Devices

FDA Warns Taiwanese, Australian X-ray Firms

David McFarland

— 1 min read
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FDA has sent Warning Letters to two overseas manufacturers of x-ray equipment. The 10/18 letter to Rolence Ent. Inc. in Taoyuan City, Taiwan, follows a 7/8-7/11 inspection there that found Quality System Regulation violations in the manufacturing of the XR-01 portable x-ray system. The specific violations were:

  • failure to establish and maintain adequate procedures to control the design of the device to ensure that specified design requirements are met;
  • failure to establish and maintain adequate procedures for implementing corrective and preventive action;
  • failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  • failure to identify by suitable means the acceptance status of product to indicate the conformance or nonconformance of product with acceptance criteria;
  • failure to validate computer software for its intended use according to an established protocol;
  • failure to establish and maintain acceptance procedures to control labeling activities; and
  • failure to develop, maintain, and implement written medical device reporting procedures.

The letter says the firm’s responses to the inspection observations were not adequate. Rolence was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.

A 9/10 Warning Letter to Micro-X Ltd. in Tonsley, Australia, says the company manufactures the Micro-X Rover Mobile X-ray Systems. Quality System Regulations violations found in a 5/20-5/23 inspection were:

  • failure to adequately establish and maintain procedures for the identification, documentation, validation, or, where appropriate, verification, review, and approval of design changes before their implementation;
  • failure to establish and maintain procedures validating the device design;
  • failure to adequately establish and maintain procedures for implementing corrective and preventive action;
  • failure to adequately ensure complaints are evaluated to determine whether the complaint represents an event that is required to be reported to FDA;
  • failure to report a medical device removal or correction to FDA;
  • failure to notify FDA of a specific product defect and/or failure to comply with an Electronic Product Radiation Control performance standard.

The letter says the firm’s responses to the inspection observations were inadequate. Micro-X was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.

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