FDA Inspection
3D Diagnostix Inc.3D Diagnostix Inc. – FDA Inspection, Nov 21, 2025
Record Details
This FDA Inspection record concerns 3D Diagnostix Inc., with an inspection on November 21, 2025, issued by the New England District Office, covering medical devices & rad health.
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ID · 014e653c-c6e5-4fa9-a019-f1bad4a6714d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1292268
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
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