Philips Goldway (Shenzhen) Industrial, Inc.July 30, 2015

FDA 483 - Philips Goldway (Shenzhen) Industrial, Inc. - July 30, 2015

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Record Details

Philips Goldway (Shenzhen) Industrial, Inc., a medical device manufacturer, was inspected by the FDA. The inspection revealed deficiencies in the firm's quality system, specifically concerning incomplete complaint investigation records and inadequate adherence to internal quality audit procedures. These issues indicate a failure to maintain proper documentation and ensure timely internal oversight of their quality management system.

Company: Philips Goldway (Shenzhen) Industrial, Inc.
Inspection Date: July 30, 2015
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Catherine J. Laufmann (Consumer Safety Officer)

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