We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A Jackson, Miss., devicemaker received a 16-count Form 483 from the FDA’s Detroit district office after an inspection found major problems with the company’s risk analysis, testing procedures and employee training. Some of the observations were repeated from a 2012 inspection. Read More
BD’s CareFusion subsidiary issued an update on its recall of the Avea ventilator to provide clarification on certain units of the product. The device is intended for continuous breathing support in infants through adults. Read More