FDA Inspection 953190 — Electro Medical, Inc.
The FDA completed an inspection of Electro Medical, Inc. on November 5, 2015 in Tulsa, OK. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 5, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tulsa, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |