Simplifying Global Compliance
The QMN Weekly Bulletin
Sunrise Gets 483 Over Noncompliant Chair
Aug. 10, 2012
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.
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