FDA Inspection 935245 — Enthermics Medical Systems, Inc.
The FDA completed an inspection of Enthermics Medical Systems, Inc. on Jun 26, 2015 in Menomonee Falls, WI. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 26, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Menomonee Falls, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3696 | 21 CFR 820.100(b) | Documentation |