FDA Inspection
INSUNG MEDICAL CO LTDINSUNG MEDICAL CO LTD – FDA Inspection, May 1, 2025
Record Details
This FDA Inspection record concerns INSUNG MEDICAL CO LTD, with an inspection on May 1, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2ebcd169-e237-4fab-9668-2a4d2ffcde15
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1272999
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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