The Food and Drug Administration (FDA) carried out an inspection of Surgical Direct, Inc. in Orange City on March 24, according to data posted on the FDA’s website.
During the visit, officials reviewed these focus areas:
- Compliance: Devices
- Postmarket Assurance: Devices
The report concluded that Surgical Direct, Inc. is expected to implement voluntary measures to address management operations in the company.
The FDA regularly inspects facilities nationwide to verify whether workplaces and their products comply with FDA regulations aimed at enhancing public health. Inspection findings are made available to the public.
The FDA’s website states that the agency is chiefly responsible for overseeing the safety and quality of human and animal drugs, biological products, medical supplies, and tobacco products.
Information for this article was sourced from the U.S. Food and Drug Administration. The original data is available here.