Devices

FDA Issues with Sea-Long Medical Treatment Hoods

David McFarland

— 2 min read
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An 8/22-9/8/2022 FDA inspection at Sea-Long Medical Systems in Waxahachie, TX, found Quality System Regulation and other issues in the firm’s manufacturing of several varieties of its Sea-Long Medical Treatment Hoods. A just-released 4/4 Warning Letter lists these Quality System violations:

  • failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  • failing to establish procedures for process validation where the results of a process cannot be fully verified by subsequent inspection and test; failing to validate the process with a high degree of assurance; and failing to approve the process according to established procedures;
  • failing to establish and maintain procedures for design change to ensure the identification, documentation, validation, or, where appropriate, verification, review, and approval of design changes before their implementation;
  • failing to establish and maintain procedures for corrective and preventive action;
  • failing to establish and maintain procedures to control product that does not conform to specified requirements;
  • failing to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria;
  • failing to establish and maintain procedures for acceptance of incoming products to ensure acceptance or rejection shall be documented;
  • failing to maintain device master records;
  • failing to establish and maintain procedures for device history records to ensure that the records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured per the device master record and regulatory requirements;
  • failing to establish procedures for quality audits and to conduct such audits to ensure that the quality system complies with the established quality system requirements, and to determine quality system effectiveness; and
  • failing to establish procedures for management review to ensure that management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency.

The letter says the firm holds a 5/16/2001 510(k) clearance for the Sea-Long Medical Treatment Hood with a specific indication for use as a hyperbaric chamber. However, FDA says, statements on the firm’s Web site and in materials collected during the inspection indicate that the device also is intended for noninvasive ventilation, respiratory distress/illness, acute respiratory distress syndrome, pressure support ventilation/positive end-expiratory pressure, Covid-19 treatment, and other additional uses, constituting major changes to the intended use for which the firm lacks clearance or approval.

“You have not submitted any new 510(k) in association with the statements made in the labeling of the treatment hood describing the new intended uses,” FDA says. The letter also gives several reasons why the devices are misbranded and adulterated.

Sea-Long was told 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 the work.

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