# FDA 483 - APEX (GUANGZHOU) TOOLS & ORTHOPEDICS COMPANY - February 13, 2014

Source: https://www.keypedia.com/records/483/apex-guangzhou-tools-orthopedics-company/d6ab3ea5-ad67-48e6-b037-cec465797e0c

> FDA 483 for APEX (GUANGZHOU) TOOLS & ORTHOPEDICS COMPANY on February 13, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: APEX (GUANGZHOU) TOOLS & ORTHOPEDICS COMPANY
- Inspection Date: 2014-02-13
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of APEX (GUANGZHOU) TOOLS & ORTHOPEDICS COMPANY, a medical device manufacturer in Guangzhou, China, identified one observation. The firm's procedures for the rework of nonconforming products were found to be inadequately established, specifically lacking documentation of reevaluation activities. This indicates a deficiency in their quality system regarding product control.

## Related Officers

- [investigator](https://www.keypedia.com/people/bleta-vuniqi/942c599c-2fbb-4428-925d-728ad860f846)
- [Rodney B Ross](https://www.keypedia.com/people/rodney-b-ross/9f3ff4ea-44c9-4e60-9850-7d9fd6b00008)

Company: https://www.keypedia.com/companies/apex-guangzhou-tools-orthopedics-company/441791ac-ff00-43f9-85e7-341772d30a30

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