FDA 483 - Beeken Biomedical, LLC - July 08, 2021

Beeken Biomedical, LLC, a medical device specification developer in Stoughton, MA, was cited for significant deficiencies related to the sterility and quality control of its NuStat and NuStat XR hemostatic wound dressings. The inspection revealed failures in preventing contamination, validating sterilization processes, reviewing design changes, establishing product specifications, and managing nonconforming products. These issues led to multiple sterility failures and the distribution of products exceeding sterilization limits.