The Food and Drug Administration conducted an inspection of Edge Biologicals, Inc. in Memphis on November 22, 2024, according to data posted on the FDA’s website.
The inspection covered the following areas:
- device compliance
- post-market assurance for devices
The FDA’s final report advised that Edge Biologicals, Inc. needs to address issues related to managing operations concerning device compliance and post-market assurance.
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.
