FDA WARNS DEVICEMAKER FOR MULTIPLE CGMP FAILURES
The FDA warned automatic external defibrillator (AED) maker MRL for several current good manufacturing practice (cGMP) violations and said the company's devices are adulterated and misbranded.
MRL sent three letters in response to the agency's Form 483 after inspections May 22-July 20, 2006, the warning letter said. According to the FDA, many of the company's responses to the observations were adequate.
However, according to the letter, MRL did not adequately respond to the charges of failing to:
Establish and maintain procedures for device design verification;
Maintain complaint files;
Keep a list of maintained databases for collecting failure data;
Validate data analysis databases for their intended uses;
Track and trend data according to a statistical method;
Complete nonconforming manufactured product reports;
File replacements for lost documents in a timely manner; and
Validate corrective and preventive actions.
Additionally, MRL's AEDs and portable intensive care systems were misbranded because they lacked material and information required by the medical device reporting regulation, the letter said.