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

Source: https://www.keypedia.com/records/eir/hangzhou-fushan-medical-appliances/549dd092-8d32-4919-8cd3-5ed9dd40517e

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

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## Details

- Record Type: EIR
- Company Name: Hangzhou Fushan Medical Appliances
- Inspection Date: 2014-03-06
- Product Type: devices
- Office Name: Office of Regulatory Affairs
- Summary: The provided text consists entirely of administrative information related to a Freedom of Information Act (FOIA) request, identified as #2021-4501, which was released by the FDA's Center for Devices and Radiological Health (CDRH) on May 5, 2022. The document repeatedly directs users to contact FDA/CDRH/OCE/DID for questions regarding the FOIA status. Despite the request to summarize an FDA inspection, the provided content does not contain the necessary details to formulate such a summary. Specifically, information regarding a company name, actual inspection dates, any main violations or non-compliance issues, the specific regulatory framework applied beyond the general involvement of CDRH, or any required corrective actions is absent. The only substantive references are to redacted document types such as "Nonconformity Product Report," "Annual Statistical Results and CAPA," "Training Nonconformity Product Report," and "Effectiveness Report," which indicate areas of record-keeping but provide no specific findings or details from an inspection.

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## Related Officers

- [Cso](https://www.keypedia.com/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

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

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64