There were two companies in a city associated with Burlington County that received FDA citations as a result of two inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 100% increase over the number of companies cited in the previous year.
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.
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.
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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Elan A. Cohen, Ph. D. | Drugs | 01/22/2024 | Case history records- inadequate or inadequate |
| 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 |



