The Food and Drug Administration (FDA) conducted an inspection at Ortho2 in Ames on Feb. 4, as noted in information published on the FDA’s website.
Inspectors evaluated these aspects during their visit:
- Device compliance
- Device postmarket assurance
The final inspection report found that Ortho2 did not need to make any corrections to its management operations.
The FDA conducts regular inspections of facilities across the country to confirm compliance with laws and regulations designed to ensure public health. Results of these inspections are released to the public.
According to the agency’s website, the FDA is a federal agency tasked with overseeing the safety and quality of drugs for humans and animals, biological products, medical supplies, and tobacco products.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
