Midmark 483 Calls Out CAPAs, Testing Records

A Form 483 to Midmark Corporation finds fault with corrective and preventive action (CAPA) procedures at its Versailles, Ohio, facility, as the plant did not analyze complaints for devices if they failed after the warranty period. The maker of steam sterilizers and other devices only reviews the number of overall complaints for devices older than one year, according to the Sept. 12, 2011, form. The FDA points to a complaint for a sterilizer door that blew open during a cycle, allowing instruments to fly across the room into the wall. That device was just over 1 year old, according to the form.
The GMP Letter