CAPA Failures Cited in 483

Johnson & Johnson subsidiary Micro Typing Systems did not take corrective and preventive actions (CAPAs) related to numerous medical device reports (MDRs) in a timely manner, according to a Form 483. The MDRs, received from 2004 to 2009, related to Micro Typing’s Provue device giving false negative results, most likely due to a faulty or misoriented gripper, investigators noted in the May 15 form that followed an inspection of the company’s Pompano Beach, Fla., facility. The company is addressing the observations, spokeswoman Linda Davis said.
The GMP Letter