FDA Inspection
PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD.PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. – FDA Inspection, Jun 26, 2025
Record Details
This FDA Inspection record concerns PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD., with an inspection on June 26, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- June 26, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 8142c831-bbcb-47ff-b60d-1f0f36b44871
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1275470
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 16, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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