GRANTECH CO., LTD. – FDA Warning Letter, Oct 18, 2012

On February 15, 2012, the FDA issued a Warning Letter to Valeo Corporation, Taiwan, following an inspection of its manufacturing facility, Grantech Co., LTD., in Shenzhen, China, from October 15-18, 2012. The inspection found that the firm's digital and infrared thermometers, classified as medical devices, were adulterated under section 501(h) of the Act due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

The letter detailed 12 significant violations: 1. **Failure to validate device design (21 CFR 820.30(g))**: Procedures lacked design validation processes, and documentation for the VT-601 infrared thermometer was incomplete (missing dates, lot/batch numbers, ambient temperatures). 2. **Failure to ensure design transfer to production specifications (21 CFR 820.30(h))**: Procedures did not establish design transfer processes, and the VT-601 was transferred to production before design validation and verification were approved. 3. **Failure to verify device design (21 CFR 820.30(f))**: Procedures lacked design verification processes, and VT-601 verification reports omitted names of individuals performing tests. 4. **Failure to validate processes (21 CFR 820