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

Source: https://www.keypedia.com/records/483/philips-goldway-shenzhen-industrial-inc/4a5bbe9c-26e4-4714-9cb8-738f7ebe7a76

> FDA 483 for Philips Goldway (Shenzhen) Industrial, Inc. on July 30, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philips Goldway (Shenzhen) Industrial, Inc.
- Inspection Date: 2015-07-30
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [483 - 2015-07-30](https://www.keypedia.com/records/483/philips-goldway-shenzhen-industrial-inc/818d8840-cb8d-4c0d-8d4f-2f8a8e996dad)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/catherine-j-laufmann/920b7656-2847-408d-ba15-3989283d8c94)

Company: https://www.keypedia.com/companies/philips-goldway-shenzhen-industrial-inc/d899ad7a-4efa-4c69-8405-fce6b5d50b8d

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd