The company in October originally refused the request of the FDA not to search the factory and then they returned later to seize the devices. In some countries this therapy is legal, but not in the United States and the FDA warns against some of the products use due to infections, etc. that could result. BD
SILVER SPRING, Md., Jan. 29 /PRNewswire-USNewswire/ -- At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized 77 ozone generators, models AOS-1M and AOS-1MD, from Applied Ozone Systems of Auburn, Calif. The seized goods, which are medical devices, are valued at $75,900.
The FDA advises health care professionals and consumers to discontinue use of these devices, which Applied Ozone Systems claims can treat cancer, AIDS, hepatitis, herpes, and a number of other diseases and conditions. The FDA has not determined that the seized products are safe and effective in treating the diseases or conditions, and officials at Applied Ozone Systems never responded to a Dec. 21, 2009 FDA request for a voluntary recall of these ozone generators.
In addition, the agency is concerned that patients who use these AOS ozone devices as directed by the manufacturer may believe that ozone therapy serves as an appropriate treatment and as a result delay or stop conventional or prescribed effective treatment. There is also a risk of infection from potential contamination of the applicator or catheter.
The FDA inspected Applied Ozone Systems in October 2009 after obtaining an inspection warrant when the owner of the company refused to allow agency staff to inspect the facility. The agency's inspection revealed significant deviations from the FDA's current good manufacturing practice (GMP) requirements for medical devices, and confirmed that the company has not obtained FDA marketing approval or clearance for these devices. The unapproved status of these devices and the conditions under which they were manufactured cause them to be adulterated and misbranded.
Today's seizure action was jointly conducted by the FDA and the State of California Department of Public Health, Food and Drug Branch as part of ongoing to efforts to ensure that unapproved medical devices that have not been found to be safe and effective do not enter the marketplace.