During an April 19, 2024 inspection targeting blood and blood products, Extend Fertility, LLC in New York was issued two citations by the Food and Drug Administration (FDA), according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘You did not establish and maintain procedures for testing, screening and determining the eligibility of HCT/P donors.’
- ‘HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with the Biohazard legend, a statement warning of communicable disease risks and a statement warning of the reactive test results.’
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
