FDA Inspection
DASISIMULATIONS, LLCDASISIMULATIONS, LLC – FDA Inspection, Jan 16, 2026
Record Details
This FDA Inspection record concerns DASISIMULATIONS, LLC, with an inspection on January 16, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
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ID · 334c99d4-456f-4e22-881a-60a9e85e533c
Inspection Facts
- Inspection number
- 1298644
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 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 820.40Procedures not adequately established or maintained
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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