FDA WARNING_LETTER - Tenderneeds Fertility LLC - December 13, 2019

On April 13, 2020, the FDA issued a Warning Letter to Tenderneeds Fertility, LLC, following a December 9-13, 2019 inspection. The firm, an initial importer and manufacturer of IUI and ICI kits, was found to be in violation of several regulations.

The IUI and ICI kits were deemed adulterated because they lacked premarket approval (PMA) or investigational device exemption (IDE) applications. They were also misbranded for failing to provide 510(k) notification prior to commercial distribution. Furthermore, IUI kits were misbranded due to inadequate labeling, lacking sufficient directions for use and not meeting prescription device requirements (e.g., "Rx only" statement, information for use). The FDA noted public health risks from improper home use.

The firm's labeling was found to be false or misleading, including reselling animal insemination products as human-use devices and falsely claiming FDA approval for pregnancy and ovulation tests, even using the FDA logo.

Tenderneeds Fertility was not duly registered with the FDA and failed to list its devices. The devices were also adulterated due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) good manufacturing practices. Specific QS violations included: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)). 2. Failure