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

Source: https://www.globalkeysolutions.net/records/483/home-care-technology-co-ltd/8e0affb3-9452-4322-bfc4-ec731b4c5bf9

> FDA 483 for Home Care Technology Co., Ltd. on May 21, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Home Care Technology Co., Ltd.
- Inspection Date: 2018-05-21
- Product Type: device
- Office Name: International Compliance Team
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/home-care-technology-co-ltd/3829e705-4ebc-4e55-b382-08ca78c35884

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321