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.
The FDA also cited Ogenix for failing to perform adequate testing of design changes to the device before those changes were implemented.
Craig Davis, a managing director with Ogenix, called the contents of the warning letter “pretty routine stuff.”
“Every company gets audited by the FDA periodically and this was just the result of that audit,” he said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The letter instructed Ogenix to reply to the FDA with specific steps the company has taken to address the violations noted in the warning letter. Davis said Ogenix has already done so.
The Epiflo device is made of a small oxygen concentrator and a delivery tube. It’s used in conjunction with a wound dressing “to continuously blanket the wound with near-100 percent oxygen,” according to the company.
The device is cleared by the FDA for treatment of diabetic foot ulcers, bed sores, surgical wounds and burns.
