Devices

Multiple Violations in Spectra Therapy Inspection

David McFarland

— 2 min read
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A 9/10-9/13/2024 FDA inspection at the Spectra Therapy facility in Port Huron, MI, found multiple types of violations in the firm’s manufacturing of the LASERwrap system of therapeutic heating infrared lamps. A 7/22 Warning Letter says Quality System Regulation violations were:

  • failure to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met, to demonstrate that the design was developed according to the design control requirements;
  • failure to establish and maintain procedures to control product that does not conform to specified requirements, including procedures to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, and an evaluation of nonconformance that includes a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance;
  • failure to establish and maintain procedures for implementing corrective and preventive action;
  • failure to maintain an adequate record of investigation;
  • failure to evaluate and select potential suppliers, contractors, and consultants based on their ability to meet specified requirements, including quality requirements, and to document the evaluation and selection process;
  • failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria;
  • failure to establish procedures for quality audits and to conduct such audits to assure that the quality system complies with the established quality system requirements and to determine quality system effectiveness;
  • failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies regulatory requirements and the manufacturer’s established quality policy and objectives;
  • failure to establish and maintain procedures to control all documents; and
  • failure to establish procedures for identifying training needs and to ensure that all personnel are trained to adequately perform their assigned responsibilities, and to document the training.

The letter says the firm’s device is adulterated because Spectra does not have an approved PMA or IDE in effect for the device as it is marketed. It is misbranded, FDA says, because the firm introduced it into commercial distribution for a use different from the intended use of a legally marketed generic heating lamp without submitting a premarket notification to FDA.

Medical Device Reporting violations were:

  • the firm’s written medical device reporting procedure does not establish internal systems providing for timely and effective identification, communication, and evaluation of events that may be subject to Medical Device Reporting requirements;
  • the firm’s procedure does not establish internal systems providing for a standardized review process to determine when an event meets the regulatory criteria for reporting;
  • the procedure does not establish internal systems providing for the timely transmission of complete medical device reports; and
  • the procedure does not describe how the firm will address documentation and record-keeping requirements.

The firm’s system is also misbranded, the letter says, because its units do not contain a unique device identifier.

“Our office requests that Spectra Therapy cease any activities that result in the misbranding or adulteration of the LASERwrap system, such as the commercial distribution of the device for the uses discussed,” the agency says.

Spectra was told to act promptly to correct the violations and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of each action and a schedule for completing the corrections.

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