Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 33.3% decrease from the number of companies cited in the previous month.
The citations in the county include:
- You did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.
- The eligibility of an HCT/P donor was not determined by a responsible person, based on results of donor screening and donor testing.
- HCT/Ps for which the applicable donor eligibility requirements were not met were not prominently labeled with the appropriate warning statements.
Both companies cited should take voluntary actions to correct their managing operations.
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.
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 quality, according to its website.
Company Name | Area of Business | Inspection Date | Issue Cited |
---|---|---|---|
Neurodynamics, Inc. | Devices | 02/28/2024 | Lack of Written MDR Procedures |
New Hope Fertility Center | Biologics | 02/22/2024 | Testing, screening, donor eligibility procedures |
New Hope Fertility Center | Biologics | 02/22/2024 | Responsible person to determine, document |
New Hope Fertility Center | Biologics | 02/22/2024 | Eligibility not required--warning labels |