Intrauma – FDA Inspection, May 29, 2025

Record Details

This FDA Inspection record concerns Intrauma, with an inspection on May 29, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Intrauma
Inspection Date: May 29, 2025
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Stephen D. Eich (Company Rep)

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ID · 9e0e60d9-3b8d-4de8-a56f-548c7bd44201

Inspection Facts

Inspection number: 1272214
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.184DHR content
21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces

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FDA Inspection

IntraumaMay 29, 2025