FDA Finds Weak Process Controls at Anesthesia Associates
A March 11-14 inspection of Anesthesia Associates’ San Marcos, California facility by the FDA revealed inadequate process controls.
The company manufactures and distributes reusable products for anesthesia and respiratory care, including the Jet Ventilator, a Class II life-sustaining device.
The inspection revealed that medical device reporting procedures were not maintained. The company’s medical device flow charts, which the president identified as the firm’s MDR procedures, didn't include requirements for submitting MDR reports or recordkeeping.