# FDA 483 - Kwang Yang Motor Co., Ltd. - August 16, 2018

Source: https://www.keypedia.com/records/483/kwang-yang-motor-co-ltd/12855657-ede7-4eae-a71b-f6729fcd6e3b

> FDA 483 for Kwang Yang Motor Co., Ltd. on August 16, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kwang Yang Motor Co., Ltd.
- Inspection Date: 2018-08-16
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Kwang Yang Motor Co., Ltd. in Kaohsiung, Taiwan, revealed significant deficiencies in their quality system documentation. Observations included inadequate documentation of corrective and preventive action (CAPA) activities, results of design risk analysis, and design verification results in the design history file. These issues indicate a need for improved record-keeping and quality control processes.

## Related Officers

- [Monica C. Burgos Garcia](https://www.keypedia.com/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.keypedia.com/companies/kwang-yang-motor-co-ltd/fcd835f2-f68f-4219-9266-2a635052f70c

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