Manufacturers Falling Down On Quality Data Collection And Analysis, FDA Warns / Capturing and analyzing product quality data appears to be a hiccup for many firms, but the problem can be addressed through the use of proper tools and effective monitoring of quality data sources, FDA officials explain. When quality data is added to a manufacturer’s CAPA system and properly analyzed, device problems may be discovered more quickly. / “The Silver Sheet” May 2012

Meridian Bioscience CEO John Kraeutler: How We Turned Around A Deficient Quality System / Meridian Bioscience’s quality system and company culture needed to change after the firm ran into regulatory trouble between 1999 and 2001, according to CEO John Kraeutler. “What I learned during those two years is, if you tell the FDA you’re going to do something, you really ought to do it,” he said. Meridian feared it was on the precipice of a consent decree with FDA and knew it had to act quickly. / “The Silver Sheet” May 2012

FDA Warning Letters / Hill-Rom cited for QS reg violations in relation to AC-powered patient lifts and adjustable hospital beds; maker of infant teething rings did not conduct proper CAPA activities. / “The Silver Sheet” May 2012

FDA Close-Out Letters / Close-out letters posted on the agency’s website from April 10 through May 14. / “The Silver Sheet” May 2012

News In Brief / ISO 13485 will be baseline for IMDRF single-audit work plan; U.S. Marshals seize ultrasound gel made by Pharmaceutical Innovations ISO 13485 will be baseline for IMDRF single-audit work plan. / “The Silver Sheet” May 2012