# FDA WARNING_LETTER - E-Care Technology Corp. - July 09, 2015

Source: https://www.globalkeysolutions.net/records/warning_letter/e-care-technology-corp/a6679a99-dc56-4d19-a9ff-be0393b95f7d

> FDA WARNING_LETTER for E-Care Technology Corp. on July 09, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: E-Care Technology Corp.
- Inspection Date: 2015-07-09
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On July 6-9, 2015, an FDA inspection of E-Care Technology Co., Ltd. in Chubei City, Taiwan, revealed that their clinical electronic thermometers are adulterated and misbranded. The devices are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include:
1.  **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: Procedures lack requirements for effectiveness verification, data source specification, statistical methodology, and investigation of nonconformity causes. Three CAPAs were completed without effectiveness verification.
2.  **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: Procedures do not address evaluating complaints for Medical Device Reporting (MDR) requirements (21 CFR Part 803).
3.  **Failure to establish and maintain rework procedures (21 CFR 820.90(b)(2))**: Procedures do not require documentation of rework activities.
4.  **Failure to establish and maintain design input procedures (21 CFR 820.30(c))**: Design history files for LCT300 and LCT600 thermometers

## Related Documents

- [WARNING_LETTER - 2019-10-25](https://www.globalkeysolutions.net/records/warning_letter/e-care-technology-corp/1aad3d46-8f4f-4a17-84bd-54dd29871a20)

## Related Officers

- [Office Director](https://www.globalkeysolutions.net/people/sean-m-boyd/e9ac4789-b489-402d-8fb7-e20eed2af01f)
- [Director](https://www.globalkeysolutions.net/people/matthew-kho/fec9b025-35e7-47a5-9b0b-841048b0c258)

Company: https://www.globalkeysolutions.net/companies/e-care-technology-corp/67572fec-c8e7-4973-a9ca-3ff209f237f8

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7