During an FDA inspection on November 5, 2024, Manhattan Fertility Services, LLC in New York was cited four times for issues related to human cellular, tissue, and gene therapies, 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 screening and determining the eligibility of HCT/P donors.’
- ‘HCT/P donors were not determined to be eligible based on the results of donor screening and testing.’
- ‘Donor eligibility records are not accurate, indelible and legible.’
- ‘HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled.’
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.
