Devices

BlephEx 12-Page Warning Letter

David McFarland

— 1 min read
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A 10/30-11/19/2025 FDA inspection at the BlephEx facility in Brentwood, TN, determined that the firm manufactures the BlephEx Powered Eyelid Cleaning Sponge, the OptiVue Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVue Ophthalmic Forceps. A just-released 6/3 12-page Warning Letter lists unapproved device violations for each of the units.

It says the firm does not have an approved PMA or IDE for any of the three devices, and lists the intended uses for the devices that demonstrate that they are subject to FDA regulation.

The letter further says the eyelid sponge is misbranded because BlephEx failed to submit a report to FDA within 10 days of initiating a correction or removal. The company also failed to label any of the devices with a unique device identifier, it says.

The letter lists these Quality System Regulation violations:

  • failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  • failure to establish and maintain procedures for implementing corrective and preventive action;
  • failure to establish and maintain procedures to control the device design to ensure that specified design requirements are met;
  • failure to adequately establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants;
  • failure to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured according to the device master record and regulatory requirements;
  • failure to establish and maintain procedures for identifying training needs and to ensure that all personnel are trained to adequately perform their assigned functions; and
  • 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.

FDA says some of the inspection observations were repeated from a 2019 inspection, and all of the company’s responses to the observations were inadequate.

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

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