FDA Inspection
CMI Health, Inc.CMI Health, Inc. – FDA Inspection, May 30, 2025
Record Details
This FDA Inspection record concerns CMI Health, Inc., with an inspection on May 30, 2025, issued by the Atlanta District Office, covering medical devices & rad health.
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ID · 21914f4c-09ad-4a31-ae7b-9a387f80dfa1
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1271520
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
5- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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