Latest FDA Warning Letter

FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below:

Tenderneeds Fertility, Greenville, IN (4/13) FDA inspected the firm 12/2019 and cited 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. For example, the firm failed to establish and maintain procedures for design control. It also failed to establish and maintain a device history file for each type of device. The firm also markets pregnancy and ovulation tests, according to FDA, and numerous representations on the company’s 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. To view the letter, click here.