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

An FDA inspection of Philips Goldway (Shenzhen) Industrial, Inc., conducted from July 27-30, 2015, revealed significant deficiencies within its quality management system, impacting compliance with medical device regulations. The U.S. Food and Drug Administration's observations highlighted two main issues. Firstly, the company failed to maintain complete records for complaint investigations concerning returned medical devices. Records for products like the TC50 device, VM1, and VS3 patient monitors lacked critical information, including investigation dates, test results, and implemented corrective actions, indicating a lapse in documenting product issue resolution.

Secondly, Philips Goldway's procedures for quality audits were not adequately followed. Despite the firm's own policy requiring internal audits of its Quality Management System at least every 12 months, the inspection found a 15-month gap between audits conducted in September 2013 and December 2014. These findings necessitate that Philips Goldway implement appropriate corrective actions and provide a formal response to the FDA to ensure regulatory compliance and uphold the integrity of its quality processes for medical device manufacturing.