FDA Inspection
Elevate Textiles, Inc.Elevate Textiles, Inc. – FDA Inspection, Apr 11, 2025
Record Details
This FDA Inspection record concerns Elevate Textiles, Inc., with an inspection on April 11, 2025, issued by the Atlanta District Office, covering medical devices & rad health.
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ID · 8754eaae-69d5-44cd-9902-5f4f1ee350ba
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1266554
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
6- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(j)Design history file
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