Philips Medical Gets 483 Noting Number of Issues

Philips Medical Systems got a Form 483 noting 10 observations, including failure to conduct an internal audit of its quality system at the required interval. FDA inspectors found that 20 months had passed between internal audits on March 7, 2008, and Nov. 12, 2009, according to the form. The Seattle facility also received several observations for corrective and preventive actions, medical device reporting and complaint handling. Philips has responded to the observations, but it has received no further communication from the FDA on the inspection, company spokesman Ian Race said.
The GMP Letter