Ogenix has received a warning letter from the U.S. Food and Drug Administration related to its Epiflo oxygen therapy medical device for wound healing. The FDA’s warning letter details six specific violations uncovered during an inspection of the Florida-based company’s manufacturing facility in Beachwood, Ohio. Most of the violations deal with issues that involve documentation and record keeping. For example, the FDA cites Ogenix for failing to include in its analysis risks involving strength and durability of the Epiflo. Some field complaints cited the breakage of locks on the device, but Ogenix’s analysis didn’t reflect these risks, according to the letter.
