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

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