The FDA has issued a warning letter to Advanced Imaging Research (AIR) for its "failure to evaluate and investigate nonconforming product."
The Cleveland-based firm develops adult and pediatric radiofrequency coils for diagnostic magnetic resonance imaging (MRI) and spectroscopy. The FDA also identified the firm as the initial importer and marketer for the MRI-diagnostic neonatal incubator.
During a February review of AIR's device history records, inspectors identified 10 neonatal MRI coils that did not meet the firm's own decibel specifications. Furthermore, the firm failed to retest the coils, document nonconformance and quarantine the products, the April 20 warning letter claims.
According to the FDA, the firm's March 12 response to the inspection argued that a lack of standardized calibration and test procedures led to discrepancies, and that coil test results reviewed by the FDA investigators were valid and within specification.
The FDA warning letter also cites AIR's failure to determine if product complaints were reportable. Specifically, the agency claims AIR did not evaluate a complaint on its imported neonatal incubator, which sounded a high-frequency alarm when its power pack was turned on.
The company's investigation of the complaint blamed a faulty transistor that prevented the power supply from reaching the incubator, the agency wrote. However, the FDA claims the firm did not evaluate the complaint as "possibly being reportable" under the medical device reporting (MDR) regulation.