FDA 483 - DePuy Orthopaedics, Inc. - September 21, 2004

On September 21, 2004, FDA Investigator Robert G. R:tiff issued a Form FDA-483 to Depuy Orthopaedics, Inc., a medical device manufacturer located at PO Box 988, 700 Orthopaedic Drive, Warsaw, IN 46581-0988. The inspection, conducted from September 13, 2004, to September 21, 2004, identified two observations related to the firm's quality system.

Observation 1 noted that procedures to control the design process of the device were incomplete. Specifically, risk analysis procedures did not document the mechanism by which unacceptable risks are determined. The firm reported this issue as corrected, but it was not verified by the investigator.

Observation 2 stated that procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements were not complete. More specifically, procedures used to identify design outputs essential to the proper functioning of devices designed by the firm had not been documented. This observation was also reported as corrected by the firm but not verified.