FDAnews Device Daily Bulletin

Sunrise Medical’s GMP slips related to one of its wheelchairs led to two of five observations on a Form 483 issued for a Jan. 11-19 inspection. According to the form, Fresno, Calif.-based Sunrise installed transit brackets on a specific wheelchair model even though that particular variation had never been tested. The wheelchair “should not have been built,” the inspector wrote. A consumer complained about the chair, which led to an internal Sunrise investigation — but not to the FDA report that should have been generated under company procedures, the Form 483 states.
The GMP Letter