Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is an increase over the number of companies cited in the previous month.
The citations in the county include:
- HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with a statement warning of the reactive test results.
- Donor specimens used for testing of communicable disease agents were not collected at the appropriate time.
- Donors were not tested for evidence of infection with relevant communicable disease agents.
The company cited should take a voluntary action to correct its 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 |
|---|---|---|---|
| Regional Women's Health Group, LLC | Biologics | 04/29/2024 | Labeled re: biohazard, risks, test results |
| Regional Women's Health Group, LLC | Biologics | 04/29/2024 | Specimen collections not timely |
| Regional Women's Health Group, LLC | Biologics | 04/29/2024 | Infection with communicable disease agents |
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