FDA Inspection 1252850 — GlobalMed Holdings, LLC
The FDA completed an inspection of GlobalMed Holdings, LLC on Oct 25, 2024 in Scottsdale, AZ. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Oct 25, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 6803 | 21 CFR 807.20(a) | Devices not listed |