FDA 483 - OsteoCentric Technologies, Inc. - November 13, 2023

An FDA inspection of OsteoCentric Technologies, Inc. in Logan, UT, a medical device specification developer, revealed significant deficiencies in its quality system. The firm failed to submit a Medical Device Report for a serious injury, inadequately maintained complaint files, and did not properly document corrective and preventive actions. These issues indicate a lack of robust control over post-market surveillance and quality processes.