FDA 483 - Osseofuse International Inc. - August 26, 2021

Osseofuse International Inc., a medical device specification developer, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to maintain adequate document control procedures, leading to the distribution of medical devices based on unapproved development plans, specifications, and risk management plans. Additionally, the inspection revealed that the firm's risk analysis was inadequate, with incorrect risk evaluations resulting in an under-estimation of risk acceptability for its dental implant systems.