FDA Warns MRL, Inc., of Violations of Current Good Manufacturing Practices in Manufacture of AEDs
MedSun: Newsletter #12, February 2007
In a December 8, 2006, Warning Letter (CHI-2-07) from Food and Drug Administration (FDA) District Director Scott J. MacIntire, FDA officially warned the president of MRL, Inc., a Welch Allyn Company, of the inadequacy of the firm’s responses in August, September, and October 2006, to FDA Form 483, Inspectional Observations. Form 483 described the company’s automatic external defibrillators (AEDs) as adulterated and misbranded, based on FDA inspections of the Buffalo Grove, Illinois, manufacturing facility May 22 through July 20, 2006.
According to the warning letter, deficiencies in the MRL responses included, but were not limited to, failure 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 methods; complete nonconforming manufactured product reports; file replacements for lost documents in a timely manner; and validate corrective and preventive actions.
The warning letter also directed MRL to investigate and determine the causes of the violations and to take prompt actions to correct the violations and bring the products into compliance.