FDA Inspection
DFI Co., Ltd.DFI Co., Ltd. – FDA Inspection, Jan 9, 2025
Record Details
This FDA Inspection record concerns DFI Co., Ltd., with an inspection on January 9, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · df343436-34cf-4930-9551-5eb0705f0e95
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1260163
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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