Devices

Multiple Violations at Reset Technology Corp.

David McFarland

— 2 min read
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A 10/29-12/20/2024 inspection at Reset Technology Corp. in Irving, TX, identified multiple violations in the firm’s manufacturing of the ResetSmile partial denture device and ResetSmile impression kit device. A 6/9 Warning Letter says specific Quality System Regulation violations were:

  • failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures;
  • failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, including the identification, documentation, evaluation, segregation, and disposition of nonconforming product;
  • failure to establish and maintain procedures for rework, including retesting and reevaluation of the nonconforming product after rework to ensure that the product meets its current approved specifications and documentation of rework and reevaluation activities, including determination of any adverse effect from the rework upon the product, in the device history record;
  • failure to adequately investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary;
  • failure to adequately maintain complaint files and adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, including evaluation of complaints to determine whether the complaint represents an event that is required to be reported to FDA under the Medical Device Reporting regulations;
  • failure to adequately establish and maintain procedures for implementing corrective and preventive action;
  • failure to establish and maintain procedures to adequately control environmental conditions, which could reasonably be expected to have an adverse effect on product quality, and periodically inspect the environmental control system to verify that the system, including necessary equipment, is adequate and functioning properly;
  • failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use; and
  • failure to establish procedures for identifying needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.

The letter says the company’s responses to the inspection observations were inadequate or their adequacy could not be determined. It also lists a corrections and removals violation and unapproved device violations.

The company’s devices are misbranded, FDA says, because their labels do not include a unique device identifier. The letter also covers registration and listing violations.

Reset was told to promptly correct the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.

FDA asked that company officials attend a virtual regulatory meeting to discuss the status of the specific steps it has taken to correct the noted violations.

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