Arthrosurface, Inc. in West Bridgewater was cited once by the Food and Drug Administration (FDA) following an inspection on April 1, FDA data show.
Inspectors focused on the following aspects:
- Compliance: Devices
- Postmarket Assurance: Devices
FDA records indicate the company was cited over this issue: ‘Procedures for the validation of processes for sterilization were not adequately documented.’
The FDA conducts routine inspections nationwide to assess compliance with laws and regulations aimed at protecting public health. The results of these assessments are made available to the public.
As outlined on its website, the FDA is a federal agency that oversees the safety and quality of drugs, biological products, medical supplies, and tobacco products for both humans and animals.
Information for this article was sourced from the U.S. Food and Drug Administration. Find the source data here.
