Company: Bunnell Inc.
Product: High frequency jet ventilators and accessories for neonatal use
Failure to validate processes that cannot by fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). For example the compliant handling software program, ultrasonic sealing procedure, leak testing procedure, and injection molding procedure have not been validated. Also, changes made to the ventilator burn-in procedure process have not been validated.
FDA District: Denver District Office