# FDA 483 - KANG ZE INDUSTRIAL CO., LTD - June 12, 2019

Source: https://www.keypedia.com/records/483/kang-ze-industrial-co-ltd/45139459-b350-42cd-84ee-ba6c67ef0e95

> FDA 483 for KANG ZE INDUSTRIAL CO., LTD on June 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KANG ZE INDUSTRIAL CO., LTD
- Inspection Date: 2019-06-12
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Kang Ze Industrial Co., LTD, a medical device manufacturer in Dongguan, China, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate process validation for thermometer sheaths, insufficient labeling examination, and a lack of procedures for nonconforming product disposition. Additionally, the firm failed to adequately establish and document equipment calibration procedures, indicating a lack of robust quality control for their Class 2 disposable thermometer covers and sheaths.

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/kang-ze-industrial-co-ltd/809a5962-b346-458b-ae74-66996bf1b1f4

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd