FDA Inspection 1275470 - PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. - June 26, 2025

FDA Inspection 1275470 for PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. on June 26, 2025. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1275470 for PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. on June 26, 2025. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 820.184

21 CFR 820.22

21 CFR 820.70(c)

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Record Information

Company

PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD.

Inspection Date

June 26, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: fdae24d4-d23e-4f6b-a452-f6e35586a7f6

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