FDA WARNING_LETTER - Health-Chem Diagnostics, LLC - February 03, 2017

On December 7, 2017, the FDA issued a Warning Letter to Health-Chem Diagnostics, LLC, following an inspection from January 2 to February 3, 2017. The inspection revealed that the firm manufactures in vitro diagnostic tests, including pregnancy and Zika virus tests, which are considered devices under the Federal Food, Drug, and Cosmetic Act.

The firm's One-Step Test for Zika Virus Antibody and One-Step Test for Zika Virus IgG/IgM Antibody tests were found to be adulterated under section 501(f)(1)(B) of the Act because the firm lacked an approved premarket approval (PMA) application or an approved investigational device exemption. Additionally, these devices did not have an Emergency Use Authorization.

The devices were also deemed misbranded under section 502(o) of the Act because the firm failed to notify the FDA of its intent to introduce the devices into commercial distribution, as required by section 510(k).

The FDA requires prompt corrective action to address these violations. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts. PMA applications for Class III devices related to Quality System regulation violations will not be approved, and Certificates to Foreign Governments will be withheld until corrections are made.

Health-Chem Diagnostics, LLC must respond in writing within fifteen business days, detailing specific corrective steps, prevention plans,