# FDA 483 - Philosys Co. Ltd - March 30, 2023

Source: https://www.keypedia.com/records/483/philosys-co-ltd/1524e2da-4547-47cf-af6f-119a858b91e0

> FDA 483 for Philosys Co. Ltd on March 30, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philosys Co. Ltd
- Inspection Date: 2023-03-30
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Philosys Co. Ltd, a medical device manufacturer in Gunsan, Korea, was inspected by the FDA from March 27-30, 2023. The inspection revealed significant deficiencies in quality system record maintenance, specifically the failure to retain original equipment printouts, and inadequate employee training on updated procedures for Medical Device Reporting and Customer Complaints. These issues indicate a lack of adherence to established quality system requirements.

## Related Documents

- [WARNING_LETTER - 2018-08-30](https://www.keypedia.com/records/warning_letter/philosys-co-ltd/d6b23bd1-fc51-43f4-b194-eadbc4b473ba)

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/philosys-co-ltd/c643e67d-d3d0-4524-ae64-b40a377974a2

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