Home Care Technology Co., Ltd.May 21, 2018

FDA 483 - Home Care Technology Co., Ltd. - May 21, 2018

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Record Details

This FDA Form 483 was issued to Home Care Technology Co. Ltd. in Tainan City, Taiwan, a device manufacturer. The inspection revealed deficiencies in complaint handling procedures, specifically regarding Medical Device Reporting (MDR) requirements. Additionally, issues were noted with Device History Records not demonstrating manufacturing in accordance with Device Master Records, including inadequate testing and undefined specifications.

Company: Home Care Technology Co., Ltd.
Inspection Date: May 21, 2018
Product Type: Device
Office: International Compliance Team
Person: Stephen D. Eich (investigator)

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ID · 8e0affb3-9452-4322-bfc4-ec731b4c5bf9