FDA 483 - Synapse Biomedical Inc - October 07, 2020

An FDA inspection of Synapse Biomedical Inc. in Oberlin, OH, revealed significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately validate critical processes, including sterile packaging and cleaning, and exhibited inadequate risk analysis for its NeuRx diaphragm stimulating device. Additionally, issues were noted in documenting non-conforming products, acceptance activities, and establishing clear procedures for supplier evaluation.