FDA Inspection
Tri-anim Health Services, Inc.Tri-anim Health Services, Inc. – FDA Inspection, Aug 21, 2025
Record Details
This FDA Inspection record concerns Tri-anim Health Services, Inc., with an inspection on August 21, 2025, issued by the Cincinnati District Office, covering medical devices & rad health.
- Inspection Date
- August 21, 2025
- Product Type
- Medical Devices & Rad Health
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ID · d215228e-b81f-4815-bf1f-716a53f7ef95
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1279137
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
5- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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