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

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.