Anchor Products Gets 483 for Repeat MDR Failures

Addison, Ill.-based Anchor Products received a Form 483 with repeat observations on medical device reporting (MDR) procedures and handling of customer complaints. During a week-long May 2011 inspection of the Addison facility, the FDA’s Chicago district office found it did not submit MDR reports within 30 days of receiving information that suggested a device might have malfunctioned and led to patient injury.
The GMP Letter