FDA Inspection 1210243 — Elmed Incorporated
The FDA completed an inspection of Elmed Incorporated on July 17, 2023 in Glendale Heights, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 17, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Glendale Heights, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |