Devices

Klarity Medical Inspection Violations

David McFarland

— 2 min read
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A 2/10-2/25 FDA inspection at Klarity Medical Products, Newark, OH, found multiple violations related to the firm’s work as a specification developer and manufacturer of various body support devices used during patient radiation therapy treatment. A 6/8 Warning Letter says the Klarity BiteLok device is adulterated because the company does not have an approved PMA or IDE in effect.

The letter says FDA disagrees with the company’s position that the Klarity BiteLok is a design change for its FDA-cleared thermoplastic device classified as an accessory to a radiation therapy device. “FDA concludes that [the] Klarity BiteLok device is a different device than the thermoplastic mask … and requires its own premarket notification under Section 510(k),” FDA says.

The letter also lists these Medical Device Reporting and Quality System Regulation violations: 

  •          failing to submit any required report within 10 working days of initiating a correction or removal;
  •          failing to establish and maintain procedures for implementing corrective and preventive action;
  •          failing to demonstrate that the design was developed per the design control requirements of the Quality System Regulation;
  •          failing to establish and maintain procedures for the identification, documentation, validation, or, where appropriate, verification, review, and approval of design changes before their implementation;
  •          failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications;
  •          failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
  •          failing to establish and maintain procedures for rework, including retesting and reevaluation of the nonconforming product after the rework, to ensure that the product meets its current approved specifications and that rework and reevaluation activities are documented in the device history record;
  •          failing to establish and maintain procedures for acceptance activities; and
  •          failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.

Many of the violations were repeated from a 2008 inspection and the letter says the firm’s responses to the current inspection observations were not adequate.

Klarity was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each action and a schedule for completion. It also was told to provide on a schedule set by FDA certification by an outside expert consultant that he or she has conducted an audit of the firm’s manufacturing and quality assurance systems relative to Quality System Regulation requirements.

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