FDA Inspection
3B Medical, Inc.3B Medical, Inc. – FDA Inspection, Dec 10, 2025
Record Details
This FDA Inspection record concerns 3B Medical, Inc., with an inspection on December 10, 2025, issued by the Cincinnati District Office, covering medical devices & rad health.
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ID · 0107df57-fb15-4b72-882a-fbfd6f8a5397
Inspection Facts
- Inspection number
- 1293330
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
7- 21 CFR 803.40(b)Report of malfunction likely to cause death or injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
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