Devices

Multiple Violations in Tenderneeds Fertility Inspection

David McFarland

— 2 min read
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A 12/9-12/13/19 FDA inspection at the Tenderneeds Fertility medical device operations in Greenville, IN, found multiple violations in the firm’s work as an initial importer of devices and a manufacturer of several types of intrauterine insemination and intracervical insemination kits. A 4/13 Warning Letter says the company does not have an approved PMA or IDE application for its two types of insemination kits and that the kits are misbranded because the company did not notify FDA of its intent to introduce them into commercial distribution.

Also, the letter says, the kits are misbranded because their labeling does not contain adequate directions for use. FDA says the firm purchased products intended for use in animal insemination and resold the products as device components in its intracervical insemination kits, further rendering the kits misbranded.

The firm also markets pregnancy and ovulation tests, according to FDA, and numerous representations on the company Web site create the misleading impression of official approval of the tests. The tests are misbranded because they include the FDA logo on their boxes.

Quality System Regulation violations cited in the letter were: 

  •          failing to establish and maintain procedures for design control;
  •          failing to establish and maintain a device history file for each type of device;
  •          failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  •          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 to control product that does not conform to specified requirements;
  •          failing to establish and maintain procedures for implementing corrective and preventive actions; and
  •          failing to develop, maintain, and implement written Medical Device Reporting procedures.

At the time of the inspection, FDA says, the company manufactured anonymous donor semen, which is a human cell, tissue, or cellular or tissue-based product. FDA says it documented deviations from the regulations for such products, including failing to determine whether a donor is eligible.

Tenderneeds was told to take prompt action to correct all the violations addressed in the letter. It was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence with documentation of each step and a schedule for completing them. It also was told to participate in a 5/5 virtual regulatory meeting at which it can ask questions and provide additional information on its corrective actions.

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