FDA Notes Validation Study Observations During Inspection of Ohio Facility

Validation studies were found lacking during an FDA inspection of Synapse Biomedical’s Oberlin, Ohio, site, according to the agency’s Form 483 inspection report.

The company manufactures neurostimulation devices, including the NeuRx to decrease reliance on mechanical ventilators, and the TransAeris for preventing and treating ventilator-induced diaphragm dysfunction.

Among other observations, the FDA investigator found a lack of evidence demonstrating if a sterile barrier is maintained in packaging when the product is stored under worst-case conditions.