# PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. – FDA Inspection, Jun 26, 2025

Source: https://www.keypedia.com/records/fda_inspections/paragon-medical-device-changzhou-co-ltd/8142c831-bbcb-47ff-b60d-1f0f36b44871
Source feed: FDA_Inspections

> FDA inspection 1275470 of PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD., June 26, 2025. Classification: Voluntary Action Indicated (VAI). 3 citations under 21 CFR part 820. Form 483 issued. 2 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1275470
- Company Name: PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD.
- Inspection Date: 2025-06-26
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Compliance: Medical Devices
- Product Type: Medical Devices & Rad Health
- Center: Medical Devices & Rad Health
- Office Name: Office of Inspections and Investigations
- Citation Count: 3

## Related Documents

- [FDA Inspection 992391 - 2016-10-27](https://www.keypedia.com/records/fda_inspections/paragon-medical-device-changzhou-co-ltd/52d1559c-002d-4ca1-bbbd-7eeb0336dea1)
- [FDA Inspection 834494 - 2013-05-16](https://www.keypedia.com/records/fda_inspections/paragon-medical-device-changzhou-co-ltd/ed688993-168b-4dcf-b511-71af585fd02a)

## Related Officers

- [Company Rep](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/paragon-medical-device-changzhou-co-ltd/55417a9e-6b13-4ba9-ab19-325be34b3688

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8