# FDA WARNING_LETTER - GRANTECH CO., LTD. - October 18, 2012

Source: https://www.keypedia.com/records/warning_letter/grantech-co-ltd/c2ef1dcf-4fb3-4f9f-8847-b8ff6c02e25f

> FDA WARNING_LETTER for GRANTECH CO., LTD. on October 18, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: GRANTECH CO., LTD.
- Inspection Date: 2012-10-18
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

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Company: https://www.keypedia.com/companies/grantech-co-ltd/e1bac3af-1143-488c-90ee-10671e19b2b3

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