Arthrosurface, Inc. in West Bridgewater was cited one time by the Food and Drug Administration (FDA) following an April 1 inspection, FDA data shows.
Inspectors reviewed the following aspects during their visit:
- Compliance: Devices
- Postmarket Assurance: Devices
Records indicate the company received a citation for this issue: ‘Procedures for the validation of processes for sterilization were not adequately documented.’
The FDA regularly inspects businesses across the country to verify that their operations and products meet FDA laws and regulations that protect public health. Inspection results are made publicly available.
According to its website, the FDA is a federal agency charged with overseeing the safety and quality of human and animal drugs, biological products, medical devices, and tobacco products.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
