# FDA 483 - Hangzhou Fushan Medical Appliances - March 06, 2014

Source: https://www.keypedia.com/records/483/hangzhou-fushan-medical-appliances/f32d4591-0c53-4382-a90d-a053e6638520

> FDA 483 for Hangzhou Fushan Medical Appliances on March 06, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hangzhou Fushan Medical Appliances
- Inspection Date: 2014-03-06
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Hangzhou Fushan Medical Appliances, a medical device contract manufacturer in Hangzhou, China, was issued a one-item FDA Form 483 following an inspection from March 3-6, 2014. The inspection, which focused on Class II Speculum devices, identified an inadequacy in the firm's Nonconformity Control Procedure. Specifically, the procedure failed to address immediate corrective actions and lacked documentation for re-training activities related to defects in nonconforming plastic parts.

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Company: https://www.keypedia.com/companies/hangzhou-fushan-medical-appliances/b90a98db-3b2e-4ae3-9298-e4d9d1c910ba

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