Feeding tube manufacturer Applied Medical Technology received a warning letter from the U.S. Food and Drug Administration for manufacturing and design issues at its suburban Cleveland location.
The FDA cited seven specific violations it found in an April inspection of the medical device company’s Brecksville, Ohio, manufacturing facility.
Warning letters are considered by the FDA to be informal and advisory and don’t necessarily indicate that the FDA intends to take any punitive action against recipients.
The FDA cited was a failure to thoroughly investigate complaints about AMT’s devices. In one instance of a feeding tube that burst, the company dismissed a manufacturing defect as the reason for the problem, but didn’t provide an adequate explanation for how it was able to come to that conclusion.
Another violation involved failing to establish procedures that would ensure that specific design requirements are met. For example, AMT didn’t conduct or document formal design reviews at the appropriate stages of development for one device.
The company’s president and founder, Dr. George Picha, didn’t immediately return a call.
The company specializes in enteral feeding, a term for delivering liquid nutrients to the stomach or intestines. One of its latest products is the Mini ONE Button, a feeding tube that it says covers more surface area and minimizes leaks better than other alternatives on the market.
The FDA instructed the company to reply to the letter within 15 days and list the steps it’s taking to correct the violations uncovered in the inspection.