E-Care Technology Corp. – FDA Warning Letter, Oct 25, 2019

The FDA issued a Warning Letter to a firm in Chubei City, Taiwan, following an inspection from October 22-25, 2019, which revealed the Swaive Thermometer, a medical device, was adulterated. The firm's manufacturing processes, facilities, and controls did not conform to Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Design Validation (21 CFR 820.30(g))**: Failure to establish and maintain design validation procedures. Clinical testing lacked documentation of device configuration (lot/control numbers), and software validation was incomplete, missing documentation of software requirement and design specifications, and testing results for various display and temperature conditions. The Risk Management Report was inadequate, failing to identify all potential failure modes and risk mitigations. 2. **Equipment Suitability (21 CFR 820.72(a))**: Failure to ensure inspection, measuring, and test equipment (specifically a blackbody for thermometer calibration) was suitable for its intended purpose and capable of producing valid results. No documentation confirmed proper installation, operation, or test method validation. 3. **Complaint Handling (21 CFR 820.198(a))**: Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints, particularly for devices sold in the US by private label customers. This was a repeat observation from a